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510(k) K852088

Device
SYSTEM 1085 BODY PLETHYSMOGRAPH
Applicant
MEDICAL GRAPHICS CORP.
510(k) number
K852088
Product code
CCM  
Decision
Substantially Equivalent (SESE)
Decision date
1985-07-30
Date received
1985-05-13
Regulation
868.1750
Classification name
Plethysmograph, Pressure
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RONALD H BERGESON
Address
501 W. County Rd. E St. Paul MN US 55112 55112

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CCM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K081823MASTERSCREEN PAED - BABY BODYViasys Healthcare GmbH2009-05-18
K023796MS PAED-BABY BODYErich Jaeger GmbH2003-03-03
K9432591085 ULTIMATE E PLETHYSMOGRAPHMedical Graphics Corp.1995-04-10
K893420MASTERLAB PFT AND MASTERLAB BODY BOXQuinton, Inc.1989-06-23
K853390INFANT BODY TESTErich Jaeger, Inc.1986-02-05
K852102COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEMWarren E. Collins, Inc.1985-07-31
K843846UNIVERSAL-BODYTESTErich Jaeger, Inc.1985-02-14
K843851BODYSCREEN IIErich Jaeger, Inc.1985-02-14
K7917054200 PNEUMATIC MOUTH SHUTTERHans Rudolph, Inc.1979-10-04
K772367CHEST BELLOWS, SMALLHoneywell, Inc.1978-01-11

Legacy Summary#

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FDA Review#

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