The following data is part of a premarket notification filed by Capintec Instruments, Inc. with the FDA for Captus 500.
Device ID | K921428 |
510k Number | K921428 |
Device Name: | CAPTUS 500 |
Classification | Probe, Uptake, Nuclear |
Applicant | CAPINTEC INSTRUMENTS, INC. 540 ALPHA DR. Pittsburgh, PA 15238 |
Contact | Ann Dell |
Correspondent | Ann Dell CAPINTEC INSTRUMENTS, INC. 540 ALPHA DR. Pittsburgh, PA 15238 |
Product Code | IZD |
CFR Regulation Number | 892.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-03-24 |
Decision Date | 1992-05-28 |