TOF-WATCH

Stimulator, Nerve, Peripheral, Electric

ORGANON TEKNIKA CORP.

The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Tof-watch.

Pre-market Notification Details

• Device ID: K972698
• 510k Number: K972698
• Device Name: TOF-WATCH
• Classification: Stimulator, Nerve, Peripheral, Electric
• Applicant: ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712
• Contact: Rebecca A Rivas
• Correspondent: Rebecca A Rivas; ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712
• Product Code: KOI
• CFR Regulation Number: 868.2775 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-07-18
• Decision Date: 1997-12-16
• Summary: summary