ACCUSET SENSOR, MODEL 2000— 510(k) K001386

Substantially Equivalent

Pelvicare, Inc.

FDA 510(k) clearance K001386 for ACCUSET SENSOR, MODEL 2000, Substantially Equivalent on 2000-07-17. Applicant: Pelvicare, Inc.. Device class: 2.

Clearance details

Applicant: Pelvicare, Inc.
Product code: Code FEN
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 2000-05-02
Decision date: 2000-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Niguel, CA, US

Download summary PDF View on FDA.gov ↗

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