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FDA 510(k)

MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE

K-Number: K101280 · 2010-10-07

ApplicantMidwest Reprocessing Center, LLC
Decision Date2010-10-07
Product CodeNLF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Midwest Reprocessing Center, LLC. It received FDA 510(k) clearance on 2010-10-07 under 510(k) number K101280. 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 MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE?

MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE is a medical device that received FDA 510(k) clearance on 2010-10-07. The listed applicant is Midwest Reprocessing Center, LLC. The 510(k) number is K101280.

When did MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE receive FDA 510(k) clearance?

MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE received FDA 510(k) clearance on 2010-10-07, under 510(k) number K101280.

Who is the listed applicant for MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE?

The FDA 510(k) record lists Midwest Reprocessing Center, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE?

The FDA product code for MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE is NLF.

Related Clinical Trials

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Other records listing Midwest Reprocessing Center, LLC 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.

K111007MIDWEST REPROCESSING CENTER REPROCESSED LNCS SESSORS; MIDWEST REPROCESSING CENTER REPROCESSED OXIMAX SENSORS; MIDWEST REK101330MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS, MIDWEST REPROCESSING CENTER REPROCESSED ALP SLEK101702MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFS

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

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

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