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510(k) K841110

NEUROTRAC by Interspec, Inc. — Product Code GWK

K841110 is an FDA 510(k) premarket notification submitted by Interspec, Inc. for the device "NEUROTRAC". The FDA issued a decision of Substantially Equivalent on April 30, 1984. The device falls under product code GWK (Conditioner, Signal, Physiological), a Class II device regulated under 21 CFR 882.1845. Interspec, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1984
Date Received
February 14, 1984
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 Interspec, Inc.

  • K940671 — INTERSPEC APOGEE RX400 ULTRASOUND IMAGING SYSTEM AND DOPPLER ULTRASOUND FLOWMETE (November 22, 1994)
  • K924231 — INTERSPEC APOGEE CLA (June 14, 1993)
  • K915696 — INTERSPEC APOGEE ENDO-V PROBE AND NEEDLE GUIDE (November 24, 1992)
  • K920678 — ULTRASOUND IMAGAING SYSTEM AND DOPPLER FLOWMETER (April 2, 1992)
  • K911073 — PROBE REFILL KIT (June 6, 1991)
  • K910049 — INTERSPEC APOGEE, MODIFICATION (April 29, 1991)
  • K903839 — INTERSPEC APOGEE (November 16, 1990)
  • K900155 — INTERSPEC 2 MHZ, TRANSCRANIAL PULSED WAVE DOPPLER (October 5, 1990)
  • K892944 — INTERSPEC TRANSESOPHAGEAL PROBE MODEL 4515 (July 19, 1989)
  • K890173 — INTERSPEC APOGEE (April 14, 1989)

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