Beta C Counter
FDA 510(k) K943072 · Capintec Instruments, Inc.
510(k) numberK943072
Submission
- Device name
- Beta C Counter
- Applicant
- Capintec Instruments, Inc.
Pittsburgh, PA, US - Received
- June 28, 1994
- Decision date
- September 29, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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More from Mentor Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K935539 | Capintec CRC 35RKPT · Traditional | 02/18/1994SE |
| K930962 | Captus 2000 Wel CounterIZD · Traditional | 05/18/1993SE |
| K924586 | Captus 500 Well Detector W/Clinical Labor SoftwareIZD · Traditional | 12/03/1992SE |
| K921428 | Captus 500IZD · Traditional | 05/28/1992SE |
| K910020 | Capintec Thyroid Uptake System-Various ModelsIZO · Traditional | 04/08/1991SE |
| K905796 | Dose CalibratorKPT · Traditional | 03/18/1991SE |
Questions and answers
When was Beta C Counter cleared by the FDA?
Beta C Counter (K943072) received a 510(k) decision of Substantially Equivalent on September 29, 1994, 93 days after the submission was received.
What is the product code of K943072?
The FDA product code is KPT – Calibrator, Dose, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.1360.