Cleared Traditional

BIOSEARCH ANAL BIOFEEDBACK DEVICE

K902843 · Biosearch Medical Products, Inc. · Gastroenterology & Urology
Sep 1990
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K902843 is an FDA 510(k) clearance for the BIOSEARCH ANAL BIOFEEDBACK DEVICE, a Cystometric Gas (carbon-dioxide) On Hydraulic Device (Class II — Special Controls, product code FAP), submitted by Biosearch Medical Products, Inc. (Somerville, US). The FDA issued a Cleared decision on September 14, 1990, 78 days after receiving the submission on June 28, 1990. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1620.

Submission Details

510(k) Number K902843 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 1990
Decision Date September 14, 1990
Days to Decision 78 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code FAP — Cystometric Gas (carbon-dioxide) On Hydraulic Device
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1620

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