FMS SOLO

Arthroscope

FUTURE MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Future Medical Systems, Inc. with the FDA for Fms Solo.

Pre-market Notification Details

• Device ID: K002040
• 510k Number: K002040
• Device Name: FMS SOLO
• Classification: Arthroscope
• Applicant: FUTURE MEDICAL SYSTEMS, INC. 504 MCCORMICK DR., SUITE T Glen Burnie, MD 21061
• Contact: Patrick Janin
• Correspondent: Patrick Janin; FUTURE MEDICAL SYSTEMS, INC. 504 MCCORMICK DR., SUITE T Glen Burnie, MD 21061
• Product Code: HRX
• CFR Regulation Number: 888.1100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-07-05
• Decision Date: 2000-09-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10886705018369	K002040	000
10886705017232	K002040	000