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510(k) K820040

SC-IT IMPEDANCE TESTER by Cadwell Laboratories, Inc. — Product Code GYA

K820040 is an FDA 510(k) premarket notification submitted by Cadwell Laboratories, Inc. for the device "SC-IT IMPEDANCE TESTER". The FDA issued a decision of Substantially Equivalent on January 28, 1982. The device falls under product code GYA (Tester, Electrode/Lead, Electroencephalograph), a Class I device regulated under 21 CFR 882.1410. Cadwell Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1982
Date Received
January 7, 1982
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 Cadwell Laboratories, Inc.

  • K061706 — CADWELL EASYNET OXIMETER MODULE (March 5, 2007)
  • K061705 — CADWELL EASYNET NASAL PRESSURE MODULE (November 21, 2006)
  • K042350 — TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR (November 3, 2004)
  • K040986 — CADWELL LIMB MOVEMENT MODULE (July 1, 2004)
  • K040932 — EASYNET BODY POSITION MODULE (July 1, 2004)
  • K971214 — KILOWIN (June 11, 1998)
  • K962458 — CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER (January 13, 1997)
  • K962457 — TWO-CHANNEL PREAMPLIFIER (January 13, 1997)
  • K962455 — FOUR-CHANNEL PREAMPLIFIER (January 13, 1997)
  • K946094 — CADWELL EASY AMBULATORY EEG (September 12, 1995)

Other clearances for product code GYA

  • K883869 — DERMTRODE (September 30, 1988)
  • K854396 — RUB E-Z (May 8, 1986)
  • K830877 — AP-CHECK (June 8, 1983)
  • K781475 — ELECTRODE IMPEDANCE TESTER-MODEL 500 (September 7, 1978)

FDA data resources