The following data is part of a premarket notification filed by Huntleigh Healthcare, Inc. with the FDA for Baby Dopplex (3000).
| Device ID | K963711 |
| 510k Number | K963711 |
| Device Name: | BABY DOPPLEX (3000) |
| Classification | System, Monitoring, Perinatal |
| Applicant | HUNTLEIGH HEALTHCARE, INC. 227 RT. 33 EAST Manalapan, NJ 07726 |
| Contact | Audrey Witko |
| Correspondent | Audrey Witko HUNTLEIGH HEALTHCARE, INC. 227 RT. 33 EAST Manalapan, NJ 07726 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-16 |
| Decision Date | 1997-09-12 |
| Summary: | summary |