The following data is part of a premarket notification filed by Merivaara Instrumentarium Corp. with the FDA for Patient Trolley 545.
| Device ID | K943528 |
| 510k Number | K943528 |
| Device Name: | PATIENT TROLLEY 545 |
| Classification | Stretcher, Wheeled |
| Applicant | MERIVAARA INSTRUMENTARIUM CORP. 555 THIRTEENTH ST. N.W. Washington, DC 20004 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein MERIVAARA INSTRUMENTARIUM CORP. 555 THIRTEENTH ST. N.W. Washington, DC 20004 |
| Product Code | FPO |
| CFR Regulation Number | 880.6910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-21 |
| Decision Date | 1994-10-04 |