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510(k) K832356

Device
PORTABLE OPERAT. RM. MONITORS HS30/40
Applicant
MEDTEL PTY. LTD.
510(k) number
K832356
Product code
BZN  
Decision
Substantially Equivalent (SESE)
Decision date
1983-10-28
Date received
1983-07-18
Regulation
868.6175
Classification name
Cart, Emergency, Cardiopulmonary (excluding Equipment)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BZN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K924373ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMPInstrumed, Inc.1992-11-25
K872558CART, EMERGENCY, CARDIOPULMONARYNico Metal Products Corp.1987-07-24
K850761MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY CMedicor USA , Ltd.1985-09-19
K840264SERVO CART 170Siemens Elema AB1984-02-04
K832697RMP INTUBATION EQUIP. STORAGE TRAYRmp Co.1983-12-27
K832355CRASH CARTQuinton, Inc.1983-10-28
K772320EMERGENCY CARTPhysio-Control Corp.1978-01-03

Legacy Summary#

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FDA Review#

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