Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS

K-Number: K041127 · 2004-09-23

ApplicantSterilmed, Inc.
Decision Date2004-09-23
Product CodeNLF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS is the device name listed in this FDA 510(k) record. The listed applicant is Sterilmed, Inc.. It received FDA 510(k) clearance on 2004-09-23 under 510(k) number K041127. The device is classified under product code NLF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS?

MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS is a medical device that received FDA 510(k) clearance on 2004-09-23. The listed applicant is Sterilmed, Inc.. The 510(k) number is K041127.

When did MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS receive FDA 510(k) clearance?

MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS received FDA 510(k) clearance on 2004-09-23, under 510(k) number K041127.

Who is the listed applicant for MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS?

The FDA 510(k) record lists Sterilmed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS?

The FDA product code for MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS is NLF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sterilmed, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254149Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485)K240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology CatheterK190478Reprocessed ViewFlex™ Xtra ICE CatheterK190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyK182272Reprocessed HARMONIC ACE+ 7 Shears with Advanced HemostasisK161700SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters

View all 60 devices →

Related Devices (Code: NLF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)Stryker Sustainability SolutionsK222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)Stryker Sustainability SolutionsK211138Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (D-20), Reprocessed Pulse Oximeter Sensor (N-25), Reprocessed Pulse Oximeter Sensor (I-20), Reprocessed Pulse Oximeter Sensor (Max-A), Reprocessed Pulse Oximeter Sensor (Max-AL), Reprocessed Pulse Oximeter Sensor (Max-P), Reprocessed Pulse Oximeter Sensor (Max-N), Reprocessed Pulse Oximeter Sensor (Max-I)Stryker Sustainability SolutionsK201699Medline ReNewal Reprocessed Nellcor OxiMax SpO2 SensorSurgical Instrument and Savings Inc (Dba Medline Renewal)K191018Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive SensorsSurgical Instrument Service and Savings, Inc.K111773RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATERenu Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑