The following data is part of a premarket notification filed by Medasonics, Inc. with the FDA for Model 5320 Ted Sequential Comp. De. Comp. Limb Sle.
| Device ID | K854734 |
| 510k Number | K854734 |
| Device Name: | MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE |
| Classification | Compressor, Cardiac, External |
| Applicant | MEDASONICS, INC. 82 PIONEER WAY P.O. BOX 7268 Mountain View, CA 94042 |
| Product Code | DRM |
| CFR Regulation Number | 870.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-25 |
| Decision Date | 1986-02-10 |