The following data is part of a premarket notification filed by Capintec, Inc. with the FDA for Capintec Model 292 Electrometer.
Device ID | K980402 |
510k Number | K980402 |
Device Name: | CAPINTEC MODEL 292 ELECTROMETER |
Classification | Accelerator, Linear, Medical |
Applicant | CAPINTEC, INC. 540 ALPHA DR. Pittsburgh, PA 15238 |
Contact | Mary Anne Dell |
Correspondent | Mary Anne Dell CAPINTEC, INC. 540 ALPHA DR. Pittsburgh, PA 15238 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-02-02 |
Decision Date | 1998-04-24 |
Summary: | summary |