The following data is part of a premarket notification filed by Huntleigh Healthcare, Inc. with the FDA for Baby Dopplex 4002-twins, Model Bd4002.
| Device ID | K001882 |
| 510k Number | K001882 |
| Device Name: | BABY DOPPLEX 4002-TWINS, MODEL BD4002 |
| Classification | System, Monitoring, Perinatal |
| Applicant | HUNTLEIGH HEALTHCARE, INC. 40 CHRISTOPHER WAY Eatontown, NJ 07724 -3327 |
| Contact | Audrey A Witko |
| Correspondent | Audrey A Witko HUNTLEIGH HEALTHCARE, INC. 40 CHRISTOPHER WAY Eatontown, NJ 07724 -3327 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-21 |
| Decision Date | 2000-09-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051968032102 | K001882 | 000 |