The following data is part of a premarket notification filed by Huntleigh Diagnostics Ltd. with the FDA for Fetal Assist.
| Device ID | K002548 |
| 510k Number | K002548 |
| Device Name: | FETAL ASSIST |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-17 |
| Decision Date | 2001-03-06 |