MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION

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 Magpro, Models R30 With Magoption, X100, X100 With Magoption.

Pre-market Notification Details

• Device ID: K091940
• 510k Number: K091940
• Device Name: MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION
• 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: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-06-30
• Decision Date: 2010-03-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05713484010049	K091940	000
05713484010032	K091940	000
05713484010018	K091940	000
05713484030047	K091940	000
05713484030016	K091940	000