Calculator, Predicted Values, Pulmonary Function

Device Code: 27

Product Code(s): BTY

Device Classification Information

Device Type ID27
Device NameCalculator, Predicted Values, Pulmonary Function
Regulation DescriptionPredictive Pulmonary-function Value Calculator.
Regulation Medical SpecialtyAnesthesiology
Review PanelAnesthesiology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Respiratory Devices Branch (RPDB)
Submission Type510(k)
CFR Regulation Number868.1890 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeBTY
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID27
DeviceCalculator, Predicted Values, Pulmonary Function
Product CodeBTY
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionPredictive Pulmonary-function Value Calculator.
CFR Regulation Number868.1890 [🔎]
Premarket Reviews
ManufacturerDecision
NDD MEDIZITECHNIK AG
 
SUBSTANTIALLY EQUIVALENT
1
SHAPE MEDICAL SYSTEMS, INC
 
SUBSTANTIALLY EQUIVALENT
1
Device Problems
Calibration Problem
8
Device Operational Issue
3
Incorrect Software Programming Calculations
2
Failure To Calibrate
2
Incorrect, Inadequate Or Imprecise Result Or Readings
2
Break
1
Temperature Problem
1
Computer Software Problem
1
Low Test Results
1
Failure To Power Up
1
Application Program Problem
1
Patient Data Problem
1
Application Program Problem: Dose Calculation Error
1
Connection Problem
1
Electrical Power Problem
1
Sparking
1
Gas Leak
1
Programming Issue
1
Total Device Problems 30
Recalls
Manufacturer Recall Class Date Posted
1
Shape Medical Systems, Inc
II Feb-05-2015
2
Shape Medical Systems, Inc
II Jul-14-2014
TPLC Last Update: 2019-04-02 19:27:04

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