MODEL 580GE-64 QUADRATURE ABDOMINAL FLEX COIL

Coil, Magnetic Resonance, Specialty

MEDICAL ADVANCES, INC.

The following data is part of a premarket notification filed by Medical Advances, Inc. with the FDA for Model 580ge-64 Quadrature Abdominal Flex Coil.

Pre-market Notification Details

• Device ID: K954190
• 510k Number: K954190
• Device Name: MODEL 580GE-64 QUADRATURE ABDOMINAL FLEX COIL
• Classification: Coil, Magnetic Resonance, Specialty
• Applicant: MEDICAL ADVANCES, INC. 10437 INNOVATION DR. Milwaukee, WI 53226
• Contact: Thomas E Tynes
• Correspondent: Thomas E Tynes; MEDICAL ADVANCES, INC. 10437 INNOVATION DR. Milwaukee, WI 53226
• Product Code: MOS
• CFR Regulation Number: 892.1000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-09-06
• Decision Date: 1995-11-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884838080942	K954190	000
00884838067097	K954190	000