The following data is part of a premarket notification filed by Cp Medical with the FDA for Transducer Filter.
Device ID | K821268 |
510k Number | K821268 |
Device Name: | TRANSDUCER FILTER |
Classification | Protector, Transducer, Dialysis |
Applicant | CP MEDICAL 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FIB |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-05-03 |
Decision Date | 1982-06-23 |