The following data is part of a premarket notification filed by Michigan Instruments, Inc. with the FDA for Thumper Cardiopulmonary Resuscitator 1005.
| Device ID | K851139 |
| 510k Number | K851139 |
| Device Name: | THUMPER CARDIOPULMONARY RESUSCITATOR 1005 |
| Classification | Compressor, Cardiac, External |
| Applicant | MICHIGAN INSTRUMENTS, INC. 4717 TALON CT., S.E. Grand Rapids, MI 49512 |
| Contact | Jim Maatman |
| Correspondent | Jim Maatman MICHIGAN INSTRUMENTS, INC. 4717 TALON CT., S.E. Grand Rapids, MI 49512 |
| Product Code | DRM |
| CFR Regulation Number | 870.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-21 |
| Decision Date | 1985-05-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860682000114 | K851139 | 000 |
| 00860682000107 | K851139 | 000 |