FDA 510(k)

INFRASONICS ADULT VENTILATOR TRENDING OPTION

K-Number: K964543 · 1997-02-14

Decision Date1997-02-14

Product CodeCBK

Advisory CommitteeAN

DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

INFRASONICS ADULT VENTILATOR TRENDING OPTION 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 1997-02-14 under 510(k) number K964543. 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 INFRASONICS ADULT VENTILATOR TRENDING OPTION?

INFRASONICS ADULT VENTILATOR TRENDING OPTION is a medical device that received FDA 510(k) clearance on 1997-02-14. The listed applicant is Nellcor Puritan Bennett, Inc.. The 510(k) number is K964543.

When did INFRASONICS ADULT VENTILATOR TRENDING OPTION receive FDA 510(k) clearance?

INFRASONICS ADULT VENTILATOR TRENDING OPTION received FDA 510(k) clearance on 1997-02-14, under 510(k) number K964543.

Who is the listed applicant for INFRASONICS ADULT VENTILATOR TRENDING OPTION?

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 INFRASONICS ADULT VENTILATOR TRENDING OPTION?

The FDA product code for INFRASONICS ADULT VENTILATOR TRENDING OPTION is CBK.

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Other records listing Nellcor Puritan Bennett, Inc. as applicant

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Related Devices (Code: CBK)

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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.