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510(k) K003480

BIOFIND by Bio-Scan, Inc. — Product Code GZO

K003480 is an FDA 510(k) premarket notification submitted by Bio-Scan, Inc. for the device "BIOFIND". The FDA issued a decision of Substantially Equivalent on May 11, 2001. The device falls under product code GZO (Device, Galvanic Skin Response Measurement), a Class II device regulated under 21 CFR 882.1540. Bio-Scan, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2001
Date Received
November 9, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Galvanic Skin Response Measurement
Device Class
Class II
Regulation Number
882.1540
Review Panel
NE
Submission Type

Other clearances by Bio-Scan, Inc.

  • K013897 — SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW (May 21, 2002)
  • K925735 — EEG ANALYZER (December 3, 1993)
  • K864928 — BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDER (March 31, 1987)
  • K841684 — BIO/SCAN BIOLOG CASSETTE RECORDER (June 7, 1984)
  • K841685 — EEG ELECTRODES (June 7, 1984)
  • K841683 — Q.P. PREAMPLIFIER SYS (June 7, 1984)

Other clearances for product code GZO

  • K150804 — QBioScan (October 19, 2015)
  • K152216 — SudoC (September 24, 2015)
  • K141872 — SUDOSCAN (November 21, 2014)
  • K131568 — SUDO PATH (June 28, 2013)
  • K111308 — ZYTO HAND CRADLE (August 30, 2011)
  • K102166 — ELECTRO INTERSTITIAL SCAN (December 10, 2010)
  • K100233 — SUDOSCAN (June 14, 2010)
  • K053004 — MSAS-VANTAGE (January 13, 2006)
  • K032935 — EPI-SCAN, MODEL P 100 (November 20, 2003)
  • K023355 — ASYRA (June 24, 2003)

FDA data resources