The following data is part of a premarket notification filed by Healthdyne, Inc. with the FDA for Model 37 Uterine Contraction Activity Monitor.
| Device ID | K894030 |
| 510k Number | K894030 |
| Device Name: | MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR |
| Classification | Monitor, Uterine Contraction, External (for Use In Clinic) |
| Applicant | HEALTHDYNE, INC. 1850 PARKWAY PLACE, 12TH FLOOR Marietta, GA 30067 -8274 |
| Contact | Tim Cowart |
| Correspondent | Tim Cowart HEALTHDYNE, INC. 1850 PARKWAY PLACE, 12TH FLOOR Marietta, GA 30067 -8274 |
| Product Code | HFM |
| CFR Regulation Number | 884.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-06 |
| Decision Date | 1990-01-22 |