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FDA 510(k)

REPROCESSED MASIMO PULSE OXIMETER SENSORS

K-Number: K081238 · 2008-07-29

ApplicantAscent Healthcare Solutions
Decision Date2008-07-29
Product CodeNLF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REPROCESSED MASIMO PULSE OXIMETER SENSORS is the device name listed in this FDA 510(k) record. The listed applicant is Ascent Healthcare Solutions. It received FDA 510(k) clearance on 2008-07-29 under 510(k) number K081238. 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 REPROCESSED MASIMO PULSE OXIMETER SENSORS?

REPROCESSED MASIMO PULSE OXIMETER SENSORS is a medical device that received FDA 510(k) clearance on 2008-07-29. The listed applicant is Ascent Healthcare Solutions. The 510(k) number is K081238.

When did REPROCESSED MASIMO PULSE OXIMETER SENSORS receive FDA 510(k) clearance?

REPROCESSED MASIMO PULSE OXIMETER SENSORS received FDA 510(k) clearance on 2008-07-29, under 510(k) number K081238.

Who is the listed applicant for REPROCESSED MASIMO PULSE OXIMETER SENSORS?

The FDA 510(k) record lists Ascent Healthcare Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REPROCESSED MASIMO PULSE OXIMETER SENSORS?

The FDA product code for REPROCESSED MASIMO PULSE OXIMETER SENSORS is NLF.

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Other records listing Ascent Healthcare Solutions as applicant

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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.

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