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FDA 510(k)

ACCUSET SENSOR, MODEL 2000

K-Number: K001386 · 2000-07-17

ApplicantPelvicare, Inc.
Decision Date2000-07-17
Product CodeFEN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ACCUSET SENSOR, MODEL 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Pelvicare, Inc.. It received FDA 510(k) clearance on 2000-07-17 under 510(k) number K001386. The device is classified under product code FEN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUSET SENSOR, MODEL 2000?

ACCUSET SENSOR, MODEL 2000 is a medical device that received FDA 510(k) clearance on 2000-07-17. The listed applicant is Pelvicare, Inc.. The 510(k) number is K001386.

When did ACCUSET SENSOR, MODEL 2000 receive FDA 510(k) clearance?

ACCUSET SENSOR, MODEL 2000 received FDA 510(k) clearance on 2000-07-17, under 510(k) number K001386.

Who is the listed applicant for ACCUSET SENSOR, MODEL 2000?

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

What is the FDA product code for ACCUSET SENSOR, MODEL 2000?

The FDA product code for ACCUSET SENSOR, MODEL 2000 is FEN.

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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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