The following data is part of a premarket notification filed by Capintec, Inc. with the FDA for Crc Pc With Smart Chamber.
Device ID | K141413 |
510k Number | K141413 |
Device Name: | CRC PC WITH SMART CHAMBER |
Classification | Calibrator, Dose, Radionuclide |
Applicant | CAPINTEC, INC. 620 ALPHA DR. Pittsburgh, PA 15241 |
Contact | Mary Anne Yusko |
Correspondent | Mary Anne Yusko CAPINTEC, INC. 620 ALPHA DR. Pittsburgh, PA 15241 |
Product Code | KPT |
CFR Regulation Number | 892.1360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-05-29 |
Decision Date | 2014-06-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00859942006089 | K141413 | 000 |
00859942006072 | K141413 | 000 |