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FDA 510(k)

RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO

K-Number: K081927 · 2009-02-06

ApplicantRenu Medical, Inc.
Decision Date2009-02-06
Product CodeNLF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO is the device name listed in this FDA 510(k) record. The listed applicant is Renu Medical, Inc.. It received FDA 510(k) clearance on 2009-02-06 under 510(k) number K081927. 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 RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO?

RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO is a medical device that received FDA 510(k) clearance on 2009-02-06. The listed applicant is Renu Medical, Inc.. The 510(k) number is K081927.

When did RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO receive FDA 510(k) clearance?

RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO received FDA 510(k) clearance on 2009-02-06, under 510(k) number K081927.

Who is the listed applicant for RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO?

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

What is the FDA product code for RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO?

The FDA product code for RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO is NLF.

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Other records listing Renu Medical, Inc. as applicant

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Related Devices (Code: NLF)

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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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