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510(k) K941673

Device
MEDIAID UNIVERSAL THERMOMETER
Applicant
POLYMEDICA INDUSTRIES, INC.
510(k) number
K941673
Product code
FLK  
Decision
Substantially Equivalent (SESE)
Decision date
1994-08-25
Date received
1994-04-05
Regulation
880.2920
Classification name
Thermometer, Clinical Mercury
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ANDREW M REED
Address
581 Conference Pl. Golden, CO US 80401 80401

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FLK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K960185AMSINO CLINICAL THERMOMETERAmsia Intl., Inc.1996-03-28
K960224GERATHERM MERCUIRY FREE CLINICAL THERMOMETERRg Ent., Inc.1996-03-25
K953465KENTEMPKentron Health Care, Inc.1995-12-15
K942483CLINICAL GLASS THERMOMETERMakol Medical Instruments Corp.1995-03-28
K940394AMG MED BRAND CLINICAL GLASS THERMOMETERTechnolab Industries (Canada) , Ltd.1994-05-04
K940380AMG MED BRAND CLINICAL GLASS THERMOMETERAmg Medical, Inc.1994-05-04
K932991GUARDIAN AND ANDINO MODELSColtemp, Inc.1994-01-28
K923225LORREX HEALTH PRODUCTS - CLINICAL MERCURY THERMOMELorrex Health Products1993-06-08
K913793SIMPEX INC. ORAL AND RECTAL THERMOMETERSSimpex, Inc.1991-12-30
K911269MERCURY AND GLASS FEVER THERMOMETERSteridyne Corp.1991-05-15
K902625CLINICAL THERMOMETER; RECTAL/ORAL, INNER ARMPITLiaoning-Usa Corp.1990-10-26
K903500MASCOT THERMOTERMascot, Inc.1990-10-09
K901790THERMOMETER, MERCURY/CLINICALPerlink USA, Inc.1990-07-11
K900646MERCURY THERMOMETERS (ORAL AND RECTAL)Abel Industries, Inc.1990-07-11
K897054CLINICAL MERCURY THERMOMETERCypress Medical Products, Ltd.1990-03-22

Legacy Summary#

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FDA Review#

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