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510(k) K860558

Device
ESOPHAGEAL STETHOSCOPE
Applicant
SHARN, INC.
510(k) number
K860558
Product code
BZW  
Decision
Substantially Equivalent (SESE)
Decision date
1986-04-01
Date received
1986-02-14
Regulation
868.1910
Classification name
Stethoscope, Esophageal
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
BRUCE A TOMLINSON
Address
1300 N. Westshore Blvd. Tampa FL US 33607 33607

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BZW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K874519MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSORMon-A-Therm, Inc.1988-01-29
K844444ESOPHAGEAL STETHOSCOPEMedical Parameters, Inc.1985-01-10
K843070ESOPHAGEAL STETHOSCOPESPrimrose Medical, Inc.1984-08-24
K841574QUAZAR ESOPHAGEAL STETHOSCOPEAxiom Medical, Inc.1984-08-15
K842865ESOPHAGEAL STETHOSCOPEInmed Corp.1984-08-15
K830329ESOPHAGEAL STETHOSCOPEScience Development Corp.1983-03-11
K830218SHERIDAN/ESOPHAGEAL STETHOSCOPESheridan Catheter Corp.1983-03-09
K823703ESOPHAGEAL STETHOSCOPERsp, Inc.1983-01-07
K823126MODEL SA-1 STETHOSCOPE AUDIO AMPLIFIERElectromedics, Inc.1982-11-16
K800463ESOPHAGEAL STETHESCOPEMedical Components, Inc.1980-03-10
K790523ARGYLE ESOPHAGEAL STETHOSCOPESherwood Medical Industries1979-03-27
K771411ESOPHAGEAL STETH. TEMP. SENSORLabarge, Inc.1977-09-23

Legacy Summary#

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FDA Review#

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