The following data is part of a premarket notification filed by Sorensen Research with the FDA for Accudynamic.
| Device ID | K801048 |
| 510k Number | K801048 |
| Device Name: | ACCUDYNAMIC |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | SORENSEN RESEARCH 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-05 |
| Decision Date | 1980-05-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840619046351 | K801048 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ACCUDYNAMIC 73804193 1592880 Dead/Cancelled |
ABBOTT LABORATORIES 1989-06-02 |
![]() ACCUDYNAMIC 73314002 1220654 Dead/Cancelled |
Sorenson Research Co., Inc. 1981-06-09 |