Apex SPX Cardial
FDA 510(k) K932673 · Elscint, Inc.
510(k) numberK932673
Submission
- Device name
- Apex SPX Cardial
- Applicant
- Elscint, Inc.
Hackensack, NJ, US - Received
- June 2, 1993
- Decision date
- February 18, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Apex SPX Cardial cleared by the FDA?
Apex SPX Cardial (K932673) received a 510(k) decision of Substantially Equivalent on February 18, 1994, 261 days after the submission was received.
What is the product code of K932673?
The FDA product code is IYX – Camera, Scintillation (Gamma), a Class I (low risk) device regulated under 21 CFR 892.1100.