The following data is part of a premarket notification filed by Michigan Instruments, Inc. with the FDA for Cardiopulmunary Resuscitator.
| Device ID | K811909 |
| 510k Number | K811909 |
| Device Name: | CARDIOPULMUNARY RESUSCITATOR |
| Classification | Compressor, Cardiac, External |
| Applicant | MICHIGAN INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRM |
| CFR Regulation Number | 870.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-01 |
| Decision Date | 1981-07-16 |