The following data is part of a premarket notification filed by Merivaara Instrumentarium Corp. with the FDA for Optima Delivery Bed (models 33901, 33903, 33902, 33905).
| Device ID | K944929 |
| 510k Number | K944929 |
| Device Name: | OPTIMA DELIVERY BED (MODELS 33901, 33903, 33902, 33905) |
| Classification | Bed, Hydraulic, Adjustable Hospital |
| Applicant | MERIVAARA INSTRUMENTARIUM CORP. FIN-15150 Lahti, FI 15150 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein MERIVAARA INSTRUMENTARIUM CORP. FIN-15150 Lahti, FI 15150 |
| Product Code | FNK |
| CFR Regulation Number | 880.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-06 |
| Decision Date | 1994-11-22 |