The following data is part of a premarket notification filed by Aequitron Medical, Inc. with the FDA for External Uterine Contraction Monitor-tokodynamomet.
| Device ID | K853856 |
| 510k Number | K853856 |
| Device Name: | EXTERNAL UTERINE CONTRACTION MONITOR-TOKODYNAMOMET |
| Classification | Monitor, Uterine Contraction, External (for Use In Clinic) |
| Applicant | AEQUITRON MEDICAL, INC. 14800 28TH AVE. NORTH Minneapolis, MN 55447 -4834 |
| Contact | Robert C Samec |
| Correspondent | Robert C Samec AEQUITRON MEDICAL, INC. 14800 28TH AVE. NORTH Minneapolis, MN 55447 -4834 |
| Product Code | HFM |
| CFR Regulation Number | 884.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-16 |
| Decision Date | 1986-03-12 |