The following data is part of a premarket notification filed by Huntleigh Diagnostics Ltd. with the FDA for Modification To Fetal Assist.
| Device ID | K020390 |
| 510k Number | K020390 |
| Device Name: | MODIFICATION TO FETAL ASSIST |
| Classification | Home Uterine Activity Monitor |
| Applicant | HUNTLEIGH DIAGNOSTICS LTD. 40 CHRISTOPHER WAY Eatontown, NJ 07724 -3327 |
| Contact | Audrey Witko |
| Correspondent | Audrey Witko HUNTLEIGH DIAGNOSTICS LTD. 40 CHRISTOPHER WAY Eatontown, NJ 07724 -3327 |
| Product Code | LQK |
| CFR Regulation Number | 884.2730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-06 |
| Decision Date | 2002-04-19 |
| Summary: | summary |