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510(k) K110305

Device
CRY-ACTRACKERCAM
Applicant
BRYMILL CRYOGENIC CYSTEMS
510(k) number
K110305
Product code
FQZ  
Decision
Substantially Equivalent (SESE)
Decision date
2012-01-13
Date received
2011-02-02
Regulation
880.2900
Classification name
Thermometer, Clinical Color Change
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Special
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
CLAUDIO RUSSO
Address
Bldg. 2, 105 Windermere Ave. Ellington CT US 06029 06029

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FQZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K963049STERI-AID KITSteri-Aid, Inc.1996-11-12
K946046DEROYAL TECHNOLOGICES, INC. LIQUID CRYSTAL SKIN TEMPERATURE STRIPDeroyal Critical Care, Div. Deroyal Technologies1995-07-19
K894893POINT CHECKER COLOR STRIP THERMOMETERKyowa Medex Co., Ltd.1990-04-05
K884612FRANKLIN COLLECTOR(R)Franklin Diagnostics, Inc.1989-03-27
K881286TEMPA-DOT CLINICAL THERMOMETER SHEATHPymah Corp.1988-06-08
K863181HEALTHCHECK THERM-STRIPHealthcheck Corp.1986-09-11
K853515PEE WEE THERMOMETERSJoel R.L. Ehren Kranz1985-10-16
K822423BABY TEMP PACIFIERTrp Energy Sensors, Inc.1982-10-13
K791574MODIFIED TEMPA-DOT THERMOMETERInfo-Chem1979-09-12
K790890TEMPO2-I DISPOSABLE THERMOMETERSAirlife, Inc.1979-06-27
K772233THERMOMETER RECAL ADAPTERInfo-Chem1977-12-20
K771037THERMOMETER, SINGLE USE, STRIP, TEMPADOTInfo-Chem1977-06-27
K771038THERMOMETER, SINGLE USE, STRIP, TEMPADOTOrganon, Inc.1977-06-27

Legacy Summary#

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FDA Review#

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