The following data is part of a premarket notification filed by Capintec, Inc. with the FDA for Cap-ria 16.
Device ID | K823240 |
510k Number | K823240 |
Device Name: | CAP-RIA 16 |
Classification | Counter (beta, Gamma) For Clinical Use |
Applicant | CAPINTEC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JJJ |
CFR Regulation Number | 862.2320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-11-01 |
Decision Date | 1982-12-03 |