K840747 is an FDA 510(k) clearance for the TOCO DATA TELEPHONE TRANSMITTER DT100P. This device is classified as a Monitor, Uterine Contraction, External (for Use In Clinic) (Class II - Special Controls, product code HFM).
Submitted by Advantage Medical Systems, Inc. (Walker, US). The FDA issued a Cleared decision on June 19, 1984, 117 days after receiving the submission on February 23, 1984.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2720.
| 510(k) Number | K840747 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 1984 |
| Decision Date | June 19, 1984 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | - |
| Product Code | HFM - Monitor, Uterine Contraction, External (for Use In Clinic) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2720 |