The following data is part of a premarket notification filed by American Sterilizer Co. with the FDA for Hall Arterial Oscillator.
| Device ID | K801063 |
| 510k Number | K801063 |
| Device Name: | HALL ARTERIAL OSCILLATOR |
| Classification | Stripper, Artery, Intraluminal |
| Applicant | AMERICAN STERILIZER CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DWX |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-06 |
| Decision Date | 1980-09-26 |