The following data is part of a premarket notification filed by Michigan Instruments, Inc. with the FDA for Thumper Cardiopulmonary Resuscitator.
| Device ID | K962237 |
| 510k Number | K962237 |
| Device Name: | THUMPER CARDIOPULMONARY RESUSCITATOR |
| Classification | Compressor, Cardiac, External |
| Applicant | MICHIGAN INSTRUMENTS, INC. 4717 TALON CT., S.E. Grand Rapids, MI 49512 |
| Contact | James D Maatman |
| Correspondent | James D 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 | 1996-06-11 |
| Decision Date | 1996-09-05 |