The following data is part of a premarket notification filed by Pneu Pac, Ltd. with the FDA for Pneupac Test Set, Pt.#500-a250.
| Device ID | K792458 |
| 510k Number | K792458 |
| Device Name: | PNEUPAC TEST SET, PT.#500-A250 |
| Classification | Compressor, Cardiac, External |
| Applicant | PNEU PAC, LTD. 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 | 1979-12-03 |
| Decision Date | 1980-02-05 |