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FDA 510(k)

BREATHE FIT

K-Number: K963326 · 1997-02-12

ApplicantCambridge Assoc.
Decision Date1997-02-12
Product CodeLWF
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BREATHE FIT is the device name listed in this FDA 510(k) record. The listed applicant is Cambridge Assoc.. It received FDA 510(k) clearance on 1997-02-12 under 510(k) number K963326. The device is classified under product code LWF. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREATHE FIT?

BREATHE FIT is a medical device that received FDA 510(k) clearance on 1997-02-12. The listed applicant is Cambridge Assoc.. The 510(k) number is K963326.

When did BREATHE FIT receive FDA 510(k) clearance?

BREATHE FIT received FDA 510(k) clearance on 1997-02-12, under 510(k) number K963326.

Who is the listed applicant for BREATHE FIT?

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

What is the FDA product code for BREATHE FIT?

The FDA product code for BREATHE FIT is LWF.

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Related Devices (Code: LWF)

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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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