Evoked Response Sys., Model 10
FDA 510(k) K771742 · Grass Instrument Co.
510(k) numberK771742
Submission
- Device name
- Evoked Response Sys., Model 10
- Applicant
- Grass Instrument Co.
Mchenry, IL, US - Received
- September 15, 1977
- Decision date
- November 22, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Evoked Response Sys., Model 10 cleared by the FDA?
Evoked Response Sys., Model 10 (K771742) received a 510(k) decision of Substantially Equivalent on November 22, 1977, 68 days after the submission was received.
What is the product code of K771742?
The FDA product code is GWK – Conditioner, Signal, Physiological, a Class II (moderate risk) device regulated under 21 CFR 882.1845.