K904691 is an FDA 510(k) clearance for the AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST. This device is classified as a Monitor, Uterine Contraction, External (for Use In Clinic) (Class II - Special Controls, product code HFM).
Submitted by Air-Shields Vickers, Inc. (Hatboro, US). The FDA issued a Cleared decision on February 19, 1991, 126 days after receiving the submission on October 16, 1990.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2720.
| 510(k) Number | K904691 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 1990 |
| Decision Date | February 19, 1991 |
| Days to Decision | 126 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 |