The following data is part of a premarket notification filed by Medasonics, Inc. with the FDA for Sequential Cuff Inflation Device.
| Device ID | K781358 |
| 510k Number | K781358 |
| Device Name: | SEQUENTIAL CUFF INFLATION DEVICE |
| Classification | Sleeve, Limb, Compressible |
| Applicant | MEDASONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-08 |
| Decision Date | 1978-09-20 |