COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65

Stimulator, Electrical, Evoked Response

TONICA ELEKTRONIK A/S

The following data is part of a premarket notification filed by Tonica Elektronik A/s with the FDA for Coils, Models Mcf-b65, Mcf-75, Mcf-125 And Cool-b65.

Pre-market Notification Details

• Device ID: K071821
• 510k Number: K071821
• Device Name: COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65
• Classification: Stimulator, Electrical, Evoked Response
• Applicant: TONICA ELEKTRONIK A/S LUCERNEMARKEN 15 Farum, DK 3520
• Contact: Lise Terkelsen
• Correspondent: Lise Terkelsen; TONICA ELEKTRONIK A/S LUCERNEMARKEN 15 Farum, DK 3520
• Product Code: GWF
• CFR Regulation Number: 882.1870 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-07-03
• Decision Date: 2007-07-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05713484020130	K071821	000
05713484020123	K071821	000
05713484020116	K071821	000
05713484020093	K071821	000
05713484020055	K071821	000
05713484020031	K071821	000
05713484020024	K071821	000
05713484020109	K071821	000