The following data is part of a premarket notification filed by Huntleigh Healthcare Ltd. with the FDA for Dopplex Centrale.
| Device ID | K060230 |
| 510k Number | K060230 |
| Device Name: | DOPPLEX CENTRALE |
| Classification | System, Monitoring, Perinatal |
| Applicant | HUNTLEIGH HEALTHCARE LTD. 35 PORTMANMOOR RD. Cardiff, South Glamorgan, GB Cf24 5hn |
| Contact | Huw Jones |
| Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-01-30 |
| Decision Date | 2006-03-23 |
| Summary: | summary |