510(k) K781289

PREAMPLIFIER MODEL 113 by Princeton Applied Research Corp. — Product Code GWL

K781289 is an FDA 510(k) premarket notification submitted by Princeton Applied Research Corp. for the device "PREAMPLIFIER MODEL 113". The FDA issued a decision of Substantially Equivalent on September 14, 1978. The device falls under product code GWL (Amplifier, Physiological Signal), a Class II device regulated under 21 CFR 882.1835. Princeton Applied Research Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1978
Date Received
July 27, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplifier, Physiological Signal
Device Class
Class II
Regulation Number
882.1835
Review Panel
NE
Submission Type