The following data is part of a premarket notification filed by Advantage Medical Systems, Inc. with the FDA for Toco Data Telephone Transmitter Dt100p.
| Device ID | K840747 |
| 510k Number | K840747 |
| Device Name: | TOCO DATA TELEPHONE TRANSMITTER DT100P |
| Classification | Monitor, Uterine Contraction, External (for Use In Clinic) |
| Applicant | ADVANTAGE MEDICAL SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HFM |
| CFR Regulation Number | 884.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-23 |
| Decision Date | 1984-06-19 |