Nuclear Laser Alignment System for Cardic Stress
FDA 510(k) K860472 · Nuclear Diagnostics, Inc.
510(k) numberK860472
Submission
- Device name
- Nuclear Laser Alignment System for Cardic Stress
- Applicant
- Nuclear Diagnostics, Inc.
Springfield, MO, US - Received
- February 6, 1986
- Decision date
- July 3, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Nuclear Laser Alignment System for Cardic Stress cleared by the FDA?
Nuclear Laser Alignment System for Cardic Stress (K860472) received a 510(k) decision of Substantially Equivalent on July 3, 1986, 147 days after the submission was received.
What is the product code of K860472?
The FDA product code is IWE – Monitor, Patient Position, Light-Beam, a Class I (low risk) device regulated under 21 CFR 892.5780.