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510(k) K780340

Device
IMV SYSTEM
Applicant
LKB INSTRUMENTS, INC.
510(k) number
K780340
Product code
CBD  
Decision
Substantially Equivalent (SESE)
Decision date
1978-11-27
Date received
1978-03-01
Regulation
880.6740
Classification name
Bottle, Collection, Breathing System (calibrated)
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
KS US

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CBD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K770665VALVE, PRESSURE, DEMANDMcgaw Respiratory Therapy1977-04-15
K770369VACON TMDiemolding Corp.1977-03-01

Legacy Summary#

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FDA Review#

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