The following data is part of a premarket notification filed by Michigan Instruments, Inc. with the FDA for Thumper, Model: 1008.
| Device ID | K073079 |
| 510k Number | K073079 |
| Device Name: | THUMPER, MODEL: 1008 |
| Classification | Compressor, Cardiac, External |
| Applicant | MICHIGAN INSTRUMENTS, INC. 555 THIRTEENTH ST., NW Washington, DC 20004 |
| Contact | Howard M Hostein |
| Correspondent | Howard M Hostein MICHIGAN INSTRUMENTS, INC. 555 THIRTEENTH ST., NW Washington, DC 20004 |
| Product Code | DRM |
| CFR Regulation Number | 870.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-31 |
| Decision Date | 2008-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860682000121 | K073079 | 000 |