The following data is part of a premarket notification filed by Capintec Instruments, Inc. with the FDA for Captus 500 Well Detector W/clinical Labor Software.
| Device ID | K924586 |
| 510k Number | K924586 |
| Device Name: | CAPTUS 500 WELL DETECTOR W/CLINICAL LABOR SOFTWARE |
| Classification | Probe, Uptake, Nuclear |
| Applicant | CAPINTEC INSTRUMENTS, INC. 540 ALPHA DR. Pittsburgh, PA 15238 |
| Contact | Anne Dell |
| Correspondent | Anne 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 | 1992-09-10 |
| Decision Date | 1992-12-03 |