The following data is part of a premarket notification filed by Namic with the FDA for Continuous Flush Device.
Device ID | K813549 |
510k Number | K813549 |
Device Name: | CONTINUOUS FLUSH DEVICE |
Classification | Transducer, Blood-pressure, Extravascular |
Applicant | NAMIC 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DRS |
CFR Regulation Number | 870.2850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-12-21 |
Decision Date | 1982-01-12 |