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 |