The following data is part of a premarket notification filed by Cinventa Ab with the FDA for Babyrocker.
| Device ID | K881019 |
| 510k Number | K881019 |
| Device Name: | BABYROCKER |
| Classification | Bed, Pediatric Open Hospital |
| Applicant | CINVENTA AB UTLANDAGATAN 24 S-412 80 GOTEBORG Sweden, SE |
| Contact | G Rosen |
| Correspondent | G Rosen CINVENTA AB UTLANDAGATAN 24 S-412 80 GOTEBORG Sweden, SE |
| Product Code | FMS |
| CFR Regulation Number | 880.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-10 |
| Decision Date | 1988-06-07 |