The following data is part of a premarket notification filed by Air-shields Vickers, Inc. with the FDA for Air-shields Vickers Telescan Telecom Display Syst.
| Device ID | K904691 |
| 510k Number | K904691 |
| Device Name: | AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST |
| Classification | Monitor, Uterine Contraction, External (for Use In Clinic) |
| Applicant | AIR-SHIELDS VICKERS, INC. 330 JACKSONVILLE RD. Hatboro, PA 19040 |
| Contact | Francis X Casey |
| Correspondent | Francis X Casey AIR-SHIELDS VICKERS, INC. 330 JACKSONVILLE RD. Hatboro, PA 19040 |
| Product Code | HFM |
| CFR Regulation Number | 884.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-16 |
| Decision Date | 1991-02-19 |