MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS

Coil, Magnetic Resonance, Specialty

INVIVO CORPORATION

The following data is part of a premarket notification filed by Invivo Corporation with the FDA for Models Hrs-63-8 And Hrs-127-8 Shoulder Array Coils.

Pre-market Notification Details

• Device ID: K053017
• 510k Number: K053017
• Device Name: MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS
• Classification: Coil, Magnetic Resonance, Specialty
• Applicant: INVIVO CORPORATION N27 W23676 PAUL RD. Pewaukee, WI 53072
• Contact: Thomas Schubert
• Correspondent: Thomas Schubert; INVIVO CORPORATION N27 W23676 PAUL RD. Pewaukee, WI 53072
• Product Code: MOS
• CFR Regulation Number: 892.1000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-10-26
• Decision Date: 2005-11-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884838086296	K053017	000
00884838086234	K053017	000
00884838067387	K053017	000
00884838067318	K053017	000
00884838066687	K053017	000
00884838066472	K053017	000
00884838066465	K053017	000
00884838066236	K053017	000
00884838088535	K053017	000