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510(k) K893760

Device
CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004
Applicant
NOVA-VENTRX
510(k) number
K893760
Product code
BZO  
Decision
Substantially Equivalent (SESE)
Decision date
1989-08-10
Date received
1989-05-19
Regulation
868.5975
Classification name
Set, Tubing And Support, Ventilator (w Harness)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
BERNARD R PALUCH
Address
4309 Regency Dr. Wheeling IL US 60025 60025

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BZO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K953784UNICOR, INC. CORRUGATED TUBINGUnicor, Inc.1995-09-19
K953785UNICOR, INC. VENTILATOR HOSESUnicor, Inc.1995-09-18
K952022PRIMA VOLUMN VENTILATORSSPrima, Inc.1995-05-22
K952012PRIMA CUSTOM ANESTESIA CIRCUITPrima, Inc.1995-05-22
K952011PRIMA BREATHING BAGSPrima, Inc.1995-05-22
K952010PRIMA VENTILATOR HOSESPrima, Inc.1995-05-22
K945740INFANT FLOW SYSTEMHamilton Medical, Inc.1995-03-23
K944531PRIMA, INC. CORRUGATED TUBINGPrima, Inc.1994-12-02
K942572VOLUME VENTILATORMed-Plastics Intl., Inc.1994-06-10
K942569VENTILATOR HOSEMed-Plastics Intl., Inc.1994-06-10
K935582TUBE, INHALER OXYGENPuritas Health Care, Inc.1994-01-14
K934753STAR BREATHING CIRCUITSInfrasonics Corp.1993-10-27
K932706PRECISION MED PRODUCTS LTD. VENTILATOR HOSEPrecision Med Products, Ltd.1993-07-23
K932712PRECISION MED PRODUCTS LTD VOLUME VENTILATORSPrecision Med Products, Ltd.1993-07-22
K932560VOLUME VENTILATORSLife Shield Healthcare Products, Inc.1993-07-22

Legacy Summary#

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FDA Review#

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