The following data is part of a premarket notification filed by Surgi-med, Inc. with the FDA for Paragon 8500 Cardio-pulmonary Bed.
| Device ID | K872924 |
| 510k Number | K872924 |
| Device Name: | PARAGON 8500 CARDIO-PULMONARY BED |
| Classification | Bed, Ac-powered Adjustable Hospital |
| Applicant | SURGI-MED, INC. 815 TERMINAL RD. Lansing, MI 48906 |
| Contact | Donald J Propp |
| Correspondent | Donald J Propp SURGI-MED, INC. 815 TERMINAL RD. Lansing, MI 48906 |
| Product Code | FNL |
| CFR Regulation Number | 880.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-27 |
| Decision Date | 1987-10-09 |