The following data is part of a premarket notification filed by Huntleigh Healthcare, Inc. with the FDA for Baby Dopplex 3002 (bd3002).
| Device ID | K010894 |
| 510k Number | K010894 |
| Device Name: | BABY DOPPLEX 3002 (BD3002) |
| Classification | System, Monitoring, Perinatal |
| Applicant | HUNTLEIGH HEALTHCARE, INC. 35 PORTMANMOOR ROAD Cardiff, GB Cf24 5hn |
| Contact | B.j. Colleypriest |
| Correspondent | B.j. Colleypriest HUNTLEIGH HEALTHCARE, INC. 35 PORTMANMOOR ROAD Cardiff, GB Cf24 5hn |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-26 |
| Decision Date | 2001-04-25 |