Apex 215M Mobile Anger Camera
FDA 510(k) K884673 · Elscint, Inc.
510(k) numberK884673
Submission
- Device name
- Apex 215M Mobile Anger Camera
- Applicant
- Elscint, Inc.
Boston, MA, US - Received
- November 8, 1988
- Decision date
- April 14, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Apex 215M Mobile Anger Camera cleared by the FDA?
Apex 215M Mobile Anger Camera (K884673) received a 510(k) decision of Substantially Equivalent on April 14, 1989, 157 days after the submission was received.
What is the product code of K884673?
The FDA product code is IYX – Camera, Scintillation (Gamma), a Class I (low risk) device regulated under 21 CFR 892.1100.