510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K150804Substantially Equivalent

QBioScan

Medeia Inc, Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K150804 is the FDA 510(k) clearance record for QBioScan, a class II device, cleared for Medeia, Inc. on under FDA product code GZO (Device, Galvanic Skin Response Measurement). FDA records list 4 510(k) clearances for Medeia, Inc., from to . As of , FDA records show no recalls naming K150804.

Clearance record

Decision date
Received
(207 days to decision)
Product code
GZO Device, Galvanic Skin Response Measurement
Regulation
21 CFR 882.1540
Device class
Class II
Review panel
Neurology
Applicant
Medeia, Inc. 80 S. W. 8th St. Suite 200, Miami FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GZO

Trailing 12 months

FDA records hold no clearances under product code GZO in the trailing twelve months.

FDA records show no clearances under product code GZO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GZO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260