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FDA 510(k)

AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1

K-Number: K081767 · 2009-01-09

ApplicantAmnisure International, LLC
Decision Date2009-01-09
Product CodeNQM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1 is the device name listed in this FDA 510(k) record. The listed applicant is Amnisure International, LLC. It received FDA 510(k) clearance on 2009-01-09 under 510(k) number K081767. The device is classified under product code NQM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1?

AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1 is a medical device that received FDA 510(k) clearance on 2009-01-09. The listed applicant is Amnisure International, LLC. The 510(k) number is K081767.

When did AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1 receive FDA 510(k) clearance?

AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1 received FDA 510(k) clearance on 2009-01-09, under 510(k) number K081767.

Who is the listed applicant for AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1?

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

What is the FDA product code for AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1?

The FDA product code for AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1 is NQM.

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Related Devices (Code: NQM)

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.

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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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