FDA 510(k)

NELLCOR PURITAN BENNETT GEMINI

K-Number: K972248 · 1997-09-12

Decision Date1997-09-12

Product CodeCBK

Advisory CommitteeAN

DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

NELLCOR PURITAN BENNETT GEMINI is the device name listed in this FDA 510(k) record. The listed applicant is Nellcor Puritan Bennett, Inc.. It received FDA 510(k) clearance on 1997-09-12 under 510(k) number K972248. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the NELLCOR PURITAN BENNETT GEMINI?

NELLCOR PURITAN BENNETT GEMINI is a medical device that received FDA 510(k) clearance on 1997-09-12. The listed applicant is Nellcor Puritan Bennett, Inc.. The 510(k) number is K972248.

When did NELLCOR PURITAN BENNETT GEMINI receive FDA 510(k) clearance?

NELLCOR PURITAN BENNETT GEMINI received FDA 510(k) clearance on 1997-09-12, under 510(k) number K972248.

Who is the listed applicant for NELLCOR PURITAN BENNETT GEMINI?

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

What is the FDA product code for NELLCOR PURITAN BENNETT GEMINI?

The FDA product code for NELLCOR PURITAN BENNETT GEMINI is CBK.

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Other records listing Nellcor Puritan Bennett, Inc. as applicant

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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.