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510(k) K150804

QBioScan by Medeia, Inc. — Product Code GZO

K150804 is an FDA 510(k) premarket notification submitted by Medeia, Inc. for the device "QBioScan". The FDA issued a decision of Substantially Equivalent on October 19, 2015. The device falls under product code GZO (Device, Galvanic Skin Response Measurement), a Class II device regulated under 21 CFR 882.1540. Medeia, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2015
Date Received
March 26, 2015
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 Medeia, Inc.

  • K212684 — BrainView QEEG Software (January 28, 2023)
  • K192753 — NeuralScan System (March 17, 2020)
  • K191266 — VitalScan ANS (January 15, 2020)

Other clearances for product code GZO

  • 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)
  • K020360 — ABR-2000 (August 29, 2002)

FDA data resources