Cleared Traditional

K951442 - FLOLAB
(FDA 510(k) Clearance)

K951442 · Synectics Medical, Inc. · Gastroenterology & Urology device

Aug 1995

Decision

148d

Days

Class 2

Risk

K951442 is an FDA 510(k) clearance for the FLOLAB. This device is classified as a Uroflowmeter (Class II - Special Controls, product code EXY).

Submitted by Synectics Medical, Inc. (S-116 28 Stockholm, SE). The FDA issued a Cleared decision on August 24, 1995, 148 days after receiving the submission on March 29, 1995.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1800.

Submission Details

510(k) Number	K951442 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 29, 1995
Decision Date	August 24, 1995
Days to Decision	148 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF