The following data is part of a premarket notification filed by Huntleigh Technology, Inc. with the FDA for M2100 Antepartum Fetal Monitor.
| Device ID | K823081 |
| 510k Number | K823081 |
| Device Name: | M2100 ANTEPARTUM FETAL MONITOR |
| Classification | System, Monitoring, Perinatal |
| Applicant | HUNTLEIGH TECHNOLOGY, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-19 |
| Decision Date | 1983-01-26 |