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FDA 510(k)

RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20

K-Number: K063661 · 2007-05-25

ApplicantRenu Medical, Inc.
Decision Date2007-05-25
Product CodeNLF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20 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 2007-05-25 under 510(k) number K063661. 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 REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20?

RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20 is a medical device that received FDA 510(k) clearance on 2007-05-25. The listed applicant is Renu Medical, Inc.. The 510(k) number is K063661.

When did RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20 receive FDA 510(k) clearance?

RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20 received FDA 510(k) clearance on 2007-05-25, under 510(k) number K063661.

Who is the listed applicant for RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20?

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 REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20?

The FDA product code for RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20 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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