The following data is part of a premarket notification filed by Huntleigh Diagnostics Ltd. with the FDA for Baby Dopplex 4000 (bd4000).
| Device ID | K001677 |
| 510k Number | K001677 |
| Device Name: | BABY DOPPLEX 4000 (BD4000) |
| Classification | System, Monitoring, Perinatal |
| Applicant | HUNTLEIGH DIAGNOSTICS LTD. 35 PORTMANMOOR ROAD Cardiff Wales, GB Cf2 2hb |
| Contact | B. J Colleypriest |
| Correspondent | B. J Colleypriest HUNTLEIGH DIAGNOSTICS LTD. 35 PORTMANMOOR ROAD Cardiff Wales, GB Cf2 2hb |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-01 |
| Decision Date | 2000-08-14 |