The following data is part of a premarket notification filed by Axon Instruments, Inc. with the FDA for Mm-1 Movement Monitor.
| Device ID | K971318 |
| 510k Number | K971318 |
| Device Name: | MM-1 MOVEMENT MONITOR |
| Classification | Transducer, Tremor |
| Applicant | AXON INSTRUMENTS, INC. 1101 CHESS DR. Foster City, CA 94404 -1102 |
| Contact | Andrew L Blatz |
| Correspondent | Andrew L Blatz AXON INSTRUMENTS, INC. 1101 CHESS DR. Foster City, CA 94404 -1102 |
| Product Code | GYD |
| CFR Regulation Number | 882.1950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-09 |
| Decision Date | 1997-07-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MM-1 MOVEMENT MONITOR 75320536 2261484 Dead/Cancelled |
ASTROS ACQUISITION SUB II, LLC 1997-07-07 |