Vista Graph Polysomnography Amplifier
FDA 510(k) K904222 · Telediagnostic Systems, Inc.
510(k) numberK904222
Submission
- Device name
- Vista Graph Polysomnography Amplifier
- Applicant
- Telediagnostic Systems, Inc.
San Francisco, CA, US - Received
- September 13, 1990
- Decision date
- January 18, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Vista Graph Polysomnography Amplifier cleared by the FDA?
Vista Graph Polysomnography Amplifier (K904222) received a 510(k) decision of Substantially Equivalent on January 18, 1991, 127 days after the submission was received.
What is the product code of K904222?
The FDA product code is GWL – Amplifier, Physiological Signal, a Class II (moderate risk) device regulated under 21 CFR 882.1835.