The following data is part of a premarket notification filed by Koven And Assoc., Inc. with the FDA for Hd-2200 Pneumo-dop Vascular Testing System.
| Device ID | K894892 |
| 510k Number | K894892 |
| Device Name: | HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEM |
| Classification | Plethysmograph, Impedance |
| Applicant | KOVEN AND ASSOC., INC. THE TRADE CENTER 300 BROOKES DRIVE, SUITE 105 St. Louis, MO 63042 |
| Contact | Paul G Koven |
| Correspondent | Paul G Koven KOVEN AND ASSOC., INC. THE TRADE CENTER 300 BROOKES DRIVE, SUITE 105 St. Louis, MO 63042 |
| Product Code | DSB |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-01 |
| Decision Date | 1989-10-27 |