The following data is part of a premarket notification filed by Midmark Corp. with the FDA for Model #535 Pacu Stretcher/bed & #530 Ed/trauma Str.
| Device ID | K894335 |
| 510k Number | K894335 |
| Device Name: | MODEL #535 PACU STRETCHER/BED & #530 ED/TRAUMA STR |
| Classification | Syringe, Piston |
| Applicant | MIDMARK CORP. 60 VISTA DR. P.O. BOX 286 Versailles, OH 45380 |
| Contact | John Oldiges |
| Correspondent | John Oldiges MIDMARK CORP. 60 VISTA DR. P.O. BOX 286 Versailles, OH 45380 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-14 |
| Decision Date | 1989-09-12 |