OHMEGA

System, Gastrointestinal Motility (electrical)

MEDICAL MEASUREMENT SYSTEMS,B.V.

The following data is part of a premarket notification filed by Medical Measurement Systems,b.v. with the FDA for Ohmega.

Pre-market Notification Details

• Device ID: K060166
• 510k Number: K060166
• Device Name: OHMEGA
• Classification: System, Gastrointestinal Motility (electrical)
• Applicant: MEDICAL MEASUREMENT SYSTEMS,B.V. COLOSSEUM 25 Enschede, NL 7521 Pv
• Contact: K. Ogink-somhorst
• Correspondent: K. Ogink-somhorst; MEDICAL MEASUREMENT SYSTEMS,B.V. COLOSSEUM 25 Enschede, NL 7521 Pv
• Product Code: FFX
• CFR Regulation Number: 876.1725 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-01-23
• Decision Date: 2006-04-21