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 |