510(k) K972698
K972698 is an FDA 510(k) premarket notification submitted by Organon Teknika Corp. for the device "TOF-WATCH". The FDA issued a decision of Substantially Equivalent on December 16, 1997. The device falls under product code KOI (Stimulator, Nerve, Peripheral, Electric), a Class II device regulated under 21 CFR 868.2775. Organon Teknika Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 1997
- Date Received
- July 18, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve, Peripheral, Electric
- Device Class
- Class II
- Regulation Number
- 868.2775
- Review Panel
- AN
- Submission Type