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FDA 510(k)

PHEM-CHEK

K-Number: K960648 · 1996-05-13

ApplicantFemtek, Inc.
Decision Date1996-05-13
Product CodeLNW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PHEM-CHEK is the device name listed in this FDA 510(k) record. The listed applicant is Femtek, Inc.. It received FDA 510(k) clearance on 1996-05-13 under 510(k) number K960648. The device is classified under product code LNW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHEM-CHEK?

PHEM-CHEK is a medical device that received FDA 510(k) clearance on 1996-05-13. The listed applicant is Femtek, Inc.. The 510(k) number is K960648.

When did PHEM-CHEK receive FDA 510(k) clearance?

PHEM-CHEK received FDA 510(k) clearance on 1996-05-13, under 510(k) number K960648.

Who is the listed applicant for PHEM-CHEK?

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

What is the FDA product code for PHEM-CHEK?

The FDA product code for PHEM-CHEK is LNW.

Related Devices (Code: LNW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K032161PHEM-ALERTFemtek,Llc.K012230PHEM-ALERTFemtek,Llc.K850858OB-PH - PH TEST PAPERUro Pharmaceuticals, Inc.

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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