FLOLAB

Uroflowmeter

SYNECTICS MEDICAL, INC.

The following data is part of a premarket notification filed by Synectics Medical, Inc. with the FDA for Flolab.

Pre-market Notification Details

• Device ID: K951442
• 510k Number: K951442
• Device Name: FLOLAB
• Classification: Uroflowmeter
• Applicant: SYNECTICS MEDICAL, INC. RENSTIENAS GATA 12, 5TR. S-116 28 Stockholm, SE S-11628
• Contact: Anna Pettersson
• Correspondent: Anna Pettersson; SYNECTICS MEDICAL, INC. RENSTIENAS GATA 12, 5TR. S-116 28 Stockholm, SE S-11628
• Product Code: EXY
• CFR Regulation Number: 876.1800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-03-29
• Decision Date: 1995-08-24