ASC-954 Integrator Amplifier
FDA 510(k) K896164 · Astro-Med, Inc.
510(k) numberK896164
Submission
- Device name
- ASC-954 Integrator Amplifier
- Applicant
- Astro-Med, Inc.
West Warwick, RI, US - Received
- October 24, 1989
- Decision date
- January 22, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was ASC-954 Integrator Amplifier cleared by the FDA?
ASC-954 Integrator Amplifier (K896164) received a 510(k) decision of Substantially Equivalent on January 22, 1990, 90 days after the submission was received.
What is the product code of K896164?
The FDA product code is GWK – Conditioner, Signal, Physiological, a Class II (moderate risk) device regulated under 21 CFR 882.1845.