Computerscope Cps-Abr

FDA 510(k) K833413 · Rc Electronics, Inc.

Substantially Equivalent

510(k) numberK833413

Submission

Device name
Computerscope Cps-Abr
Applicant
Rc Electronics, Inc.
Mchenry, IL, US
Received
September 30, 1983
Decision date
November 28, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GWL – Amplifier, Physiological Signal
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1835
Specialty
Neurology

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Questions and answers

When was Computerscope Cps-Abr cleared by the FDA?

Computerscope Cps-Abr (K833413) received a 510(k) decision of Substantially Equivalent on November 28, 1983, 59 days after the submission was received.

What is the product code of K833413?

The FDA product code is GWL – Amplifier, Physiological Signal, a Class II (moderate risk) device regulated under 21 CFR 882.1835.