Captus 500 Well Detector W/Clinical Labor Software
FDA 510(k) K924586 · Capintec Instruments, Inc.
510(k) numberK924586
Submission
- Device name
- Captus 500 Well Detector W/Clinical Labor Software
- Applicant
- Capintec Instruments, Inc.
Pittsburgh, PA, US - Received
- September 10, 1992
- Decision date
- December 3, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Captus 500 Well Detector W/Clinical Labor Software cleared by the FDA?
Captus 500 Well Detector W/Clinical Labor Software (K924586) received a 510(k) decision of Substantially Equivalent on December 3, 1992, 84 days after the submission was received.
What is the product code of K924586?
The FDA product code is IZD – Probe, Uptake, Nuclear, a Class I (low risk) device regulated under 21 CFR 892.1320.