The following data is part of a premarket notification filed by Dynamedics, Inc. with the FDA for Dynamark 1000.
| Device ID | K873979 |
| 510k Number | K873979 |
| Device Name: | DYNAMARK 1000 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | DYNAMEDICS, INC. 200 PROSPECT ST. Waltham, MA 02154 |
| Contact | Robert J Witkop |
| Correspondent | Robert J Witkop DYNAMEDICS, INC. 200 PROSPECT ST. Waltham, MA 02154 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-30 |
| Decision Date | 1987-11-27 |