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FDA 510(k)

CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20

K-Number: K012622 · 2002-07-03

ApplicantClearmedical, Inc.
Decision Date2002-07-03
Product CodeNLF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20 is the device name listed in this FDA 510(k) record. The listed applicant is Clearmedical, Inc.. It received FDA 510(k) clearance on 2002-07-03 under 510(k) number K012622. 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 CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20?

CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20 is a medical device that received FDA 510(k) clearance on 2002-07-03. The listed applicant is Clearmedical, Inc.. The 510(k) number is K012622.

When did CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20 receive FDA 510(k) clearance?

CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20 received FDA 510(k) clearance on 2002-07-03, under 510(k) number K012622.

Who is the listed applicant for CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20?

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

What is the FDA product code for CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20?

The FDA product code for CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20 is 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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