The following data is part of a premarket notification filed by Arterial Stiffness Inc. with the FDA for Asi Plethysmogrpah Analyzer.
| Device ID | K200567 |
| 510k Number | K200567 |
| Device Name: | ASI Plethysmogrpah Analyzer |
| Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Applicant | Arterial Stiffness Inc. 1000 Westgate Drive Suite 101B Saint Paul, MN 55114 |
| Contact | Jospeh Henry Shaw |
| Correspondent | Nida Shoubash Arterial Stiffness Inc. 1000 Westgate Drive Suite 101B Saint Paul, MN 55114 |
| Product Code | JOM |
| CFR Regulation Number | 870.2780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-04 |
| Decision Date | 2021-02-26 |