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FDA 510(k)

AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1

K-Number: K030849 · 2004-02-02

ApplicantN-Dia, Inc.
Decision Date2004-02-02
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1 is the device name listed in this FDA 510(k) record. The listed applicant is N-Dia, Inc.. It received FDA 510(k) clearance on 2004-02-02 under 510(k) number K030849. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1?

AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1 is a medical device that received FDA 510(k) clearance on 2004-02-02. The listed applicant is N-Dia, Inc.. The 510(k) number is K030849.

When did AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1 receive FDA 510(k) clearance?

AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1 received FDA 510(k) clearance on 2004-02-02, under 510(k) number K030849.

Who is the listed applicant for AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1?

The FDA 510(k) record lists N-Dia, Inc. 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 FMRT1?

The FDA product code for AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1 is JJX.

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Related Devices (Code: JJX)

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

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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