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510(k) K932288

Device
NEONATAL BREATHING CIRCUIT MODIFICATION
Applicant
SIMPLEX MEDICAL SYSTEMS, INC.
510(k) number
K932288
Product code
CAI  
Decision
Substantially Equivalent (SESE)
Decision date
1994-12-30
Date received
1993-05-10
Regulation
868.5240
Classification name
Circuit, Breathing (w Connector, Adaptor, Y Piece)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JAMES WEIGL
Address
3305 Springmountain Rd., #60 Las Vegas NV US 89102 89102

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CAI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K954480CONDENSATE COLLECTION KITNova-Ventrx1995-12-29
K953787UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUITUnicor, Inc.1995-09-19
K953788UNICOR, INC. GAS SAMPLING LINES & CONNECTORSUnicor, Inc.1995-09-19
K952014PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITSPrima, Inc.1995-05-22
K952016PRIMA PEDIATRIC GAS SAMPLING CIRCUITSPrima, Inc.1995-05-22
K952017PRIMA MAPLESON D CIRCUITPrima, Inc.1995-05-22
K952018PRIMA COAXIAL CIRCUITSPrima, Inc.1995-05-22
K952019PRIMA ADULT GAS SAMPLING CIRCUITSPrima, Inc.1995-05-22
K952020PRIMA PEDIATRIC ANESTHESIA CIRCUITSPrima, Inc.1995-05-22
K952009PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITSPrima, Inc.1995-05-19
K945565SPIRO-FLEXInhalation Plastics1995-01-13
K945984MERIDIAN MEDICAL SYSTEMS MAPLESON D AND MODIFIED JACKSON REESE CIRCUITSMeridian Medical Systems, Inc.1994-12-27
K944533PRIMA, INC. ADULT ANESTHESIA CIRCUITPrima, Inc.1994-11-29
K944429PRECISION THERMOPLASTIC COMPONENETS, INC. TUBINGPrecision Thermoplastic Components, Inc.1994-11-18
K945314CLEVELAND TUBING, INC. EXPANDABLE/COLLAPSIBLEMEDICAL TUBINGCleveland Tubing, Inc.1994-11-18

Legacy Summary#

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FDA Review#

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