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510(k) K781290

SIGNAL AVERAGER MODEL 4202 by Princeton Applied Research Corp. — Product Code GWK

K781290 is an FDA 510(k) premarket notification submitted by Princeton Applied Research Corp. for the device "SIGNAL AVERAGER MODEL 4202". The FDA issued a decision of Substantially Equivalent on September 15, 1978. The device falls under product code GWK (Conditioner, Signal, Physiological), a Class II device regulated under 21 CFR 882.1845. Princeton Applied Research Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1978
Date Received
July 27, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conditioner, Signal, Physiological
Device Class
Class II
Regulation Number
882.1845
Review Panel
NE
Submission Type

Other clearances by Princeton Applied Research Corp.

  • K781289 — PREAMPLIFIER MODEL 113 (September 14, 1978)

Other clearances for product code GWK

  • K060919 — ACTICAL (September 22, 2006)
  • K061870 — VITALSENSE XHR (August 31, 2006)
  • K052489 — ACTIHEART (September 27, 2005)
  • K991045 — MINI-LOGGER SERIES 2000 (September 21, 1999)
  • K905594 — NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300 (June 28, 1991)
  • K904328 — VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM (June 18, 1991)
  • K896164 — ASC-954 INTEGRATOR AMPLIFIER (January 22, 1990)
  • K882599 — NICOLET BRAINLAB SYSTEM (October 19, 1988)
  • K872290 — BIO-LOGIC BANKER (October 6, 1987)
  • K870381 — DD-VCR-64 (March 25, 1987)

FDA data resources