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510(k) K830877

AP-CHECK by General Devices — Product Code GYA

K830877 is an FDA 510(k) premarket notification submitted by General Devices for the device "AP-CHECK". The FDA issued a decision of Substantially Equivalent on June 8, 1983. The device falls under product code GYA (Tester, Electrode/Lead, Electroencephalograph), a Class I device regulated under 21 CFR 882.1410. General Devices has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1983
Date Received
March 18, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Electrode/Lead, Electroencephalograph
Device Class
Class I
Regulation Number
882.1410
Review Panel
NE
Submission Type

Other clearances by General Devices

  • K013533 — EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000) (January 18, 2002)
  • K002089 — ROSETTA-LT/ROSETTA-RX (November 21, 2000)
  • K993202 — EIM-107 PREP-CHECK (December 17, 1999)
  • K940009 — GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300 (April 14, 1995)
  • K935839 — GEMSCOM SERIES 5000, (November 10, 1994)
  • K921929 — GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION) (September 18, 1992)
  • K914889 — GEMSCOM SERIES 3000 (March 4, 1992)
  • K912008 — TRU-VIEW MULTI-CHANNEL DISPLAY (October 9, 1991)
  • K896153 — MODIFIED DR-2C/PMC 100 (January 19, 1990)
  • K862596 — DR-2C (MODIFICATION) (September 26, 1986)

Other clearances for product code GYA

  • K883869 — DERMTRODE (September 30, 1988)
  • K854396 — RUB E-Z (May 8, 1986)
  • K820040 — SC-IT IMPEDANCE TESTER (January 28, 1982)
  • K781475 — ELECTRODE IMPEDANCE TESTER-MODEL 500 (September 7, 1978)

FDA data resources