Preamplifier Model 113

FDA 510(k) K781289 · Princeton Applied Research Corp.

Substantially Equivalent

510(k) numberK781289

Submission

Device name
Preamplifier Model 113
Applicant
Princeton Applied Research Corp.
Mchenry, IL, US
Received
July 27, 1978
Decision date
September 14, 1978
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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More from Blackrock Microsystems

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Questions and answers

When was Preamplifier Model 113 cleared by the FDA?

Preamplifier Model 113 (K781289) received a 510(k) decision of Substantially Equivalent on September 14, 1978, 49 days after the submission was received.

What is the product code of K781289?

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