510(k) K971318
K971318 is an FDA 510(k) premarket notification submitted by Axon Instruments, Inc. for the device "MM-1 MOVEMENT MONITOR". The FDA issued a decision of Substantially Equivalent on July 28, 1997. The device falls under product code GYD (Transducer, Tremor), a Class II device regulated under 21 CFR 882.1950. Axon Instruments, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 1997
- Date Received
- April 9, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Tremor
- Device Class
- Class II
- Regulation Number
- 882.1950
- Review Panel
- NE
- Submission Type