ZYTO HAND CRADLE— 510(k) K111308

Substantially Equivalent

Zyto Technologies, Inc.

FDA 510(k) clearance K111308 for ZYTO HAND CRADLE, Substantially Equivalent on 2011-08-30. Applicant: Zyto Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Zyto Technologies, Inc.
Product code: Code GZO
Device class: Class 2
Regulation: 21 CFR 882.1540
Advisory panel: Neurology
Date received: 2011-05-10
Decision date: 2011-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lindon, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GZO

K150804 — QBioScan2015-10-19
K152216 — SudoC2015-09-24
K141872 — SUDOSCAN2014-11-21
K131568 — SUDO PATH2013-06-28
K102166 — ELECTRO INTERSTITIAL SCAN2010-12-10

Recalls naming K111308

K-number listed on FDA's recall record

Z-2120-2016 — The ZYTO Tower is the input device to program the software with various virtual items.Class II·Terminated·ZYTO Technologies, Inc.·20151123
Z-2121-2016 — The ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin response measurements from most coherent (the second scan is closest in time measurement to the baseline original scan) to least coherent (further away from the baseline).Class II·Terminated·ZYTO Technologies, Inc.·20151123

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111308.

Data sourced from openFDA. This site is unofficial and independent of the FDA.