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FDA 510(k)

WHISPER O2

K-Number: K931355 · 1994-03-25

ApplicantTrilogic Corp.
Decision Date1994-03-25
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

WHISPER O2 is the device name listed in this FDA 510(k) record. The listed applicant is Trilogic Corp.. It received FDA 510(k) clearance on 1994-03-25 under 510(k) number K931355. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WHISPER O2?

WHISPER O2 is a medical device that received FDA 510(k) clearance on 1994-03-25. The listed applicant is Trilogic Corp.. The 510(k) number is K931355.

When did WHISPER O2 receive FDA 510(k) clearance?

WHISPER O2 received FDA 510(k) clearance on 1994-03-25, under 510(k) number K931355.

Who is the listed applicant for WHISPER O2?

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

What is the FDA product code for WHISPER O2?

The FDA product code for WHISPER O2 is CAW.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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