The following data is part of a premarket notification filed by Capintec Instruments, Inc. with the FDA for Capintec Thyroid Uptake System-various Models.
| Device ID | K910020 |
| 510k Number | K910020 |
| Device Name: | CAPINTEC THYROID UPTAKE SYSTEM-VARIOUS MODELS |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| 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 | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-03 |
| Decision Date | 1991-04-08 |