The following data is part of a premarket notification filed by Aci Medical, Inc. with the FDA for Venapulse Models Vp-25 And Vp-50.
| Device ID | K903894 |
| 510k Number | K903894 |
| Device Name: | VENAPULSE MODELS VP-25 AND VP-50 |
| Classification | Sleeve, Limb, Compressible |
| Applicant | ACI MEDICAL, INC. 9249 GLENOAKS BL. Sun Valley, CA 91352 |
| Contact | Ed Arkans |
| Correspondent | Ed Arkans ACI MEDICAL, INC. 9249 GLENOAKS BL. Sun Valley, CA 91352 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-23 |
| Decision Date | 1991-04-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860446000329 | K903894 | 000 |