GRINDCARE

Device, Biofeedback

MEDOTECH A/S

The following data is part of a premarket notification filed by Medotech A/s with the FDA for Grindcare.

Pre-market Notification Details

• Device ID: K092675
• 510k Number: K092675
• Device Name: GRINDCARE
• Classification: Device, Biofeedback
• Applicant: MEDOTECH A/S 13417 QUIVAS ST Westminster, CO 80234
• Contact: Calley Herzog
• Correspondent: Calley Herzog; MEDOTECH A/S 13417 QUIVAS ST Westminster, CO 80234
• Product Code: HCC
• CFR Regulation Number: 882.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-09-01
• Decision Date: 2010-03-03
• Summary: summary