Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
calculator, predicted values, pulmonary function
Product Code
BTY
Regulation Number
868.1890
Device Class
2
Premarket Reviews
Manufacturer
Decision
COSMED SRL
SUBSTANTIALLY EQUIVALENT
1
ERESEARCHTECHNOLOGY GMBH
SUBSTANTIALLY EQUIVALENT
3
GUANGZHOU HOMESUN MEDICAL TECHNOLOGY CO., LTD
SUBSTANTIALLY EQUIVALENT
1
MEDICAL GRAPHICS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
NDD MEDIZINTECHNIK AG
SUBSTANTIALLY EQUIVALENT
1
SHAPE MEDICAL SYSTEMS, INC
SUBSTANTIALLY EQUIVALENT
1
VIRTUS TECHNOLOGY APS
SUBSTANTIALLY EQUIVALENT
1
VITALOGRAPH IRELAND LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2015
51
51
2016
24
24
2017
9
9
2018
5
5
2019
3
3
2020
3
3
2021
2
2
2022
2
2
2023
1
1
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
27
27
Device Stops Intermittently
11
11
Calibration Problem
8
8
Smoking
7
7
Break
6
6
Device Operational Issue
3
3
Incorrect, Inadequate or Imprecise Result or Readings
3
3
Overheating of Device
3
3
Connection Problem
3
3
Failure to Calibrate
3
3
Sparking
2
2
Temperature Problem
2
2
Incorrect Software Programming Calculations
2
2
Device Displays Incorrect Message
2
2
Loose or Intermittent Connection
2
2
Battery Problem
2
2
Failure to Power Up
2
2
Incorrect Or Inadequate Test Results
2
2
Melted
2
2
Computer Operating System Problem
2
2
Device Operates Differently Than Expected
2
2
Component Falling
1
1
Detachment Of Device Component
1
1
Low Test Results
1
1
Electrical /Electronic Property Problem
1
1
Grounding Malfunction
1
1
Power Problem
1
1
Computer Software Problem
1
1
Programming Issue
1
1
Environmental Particulates
1
1
Incorrect Measurement
1
1
Misconnection
1
1
Environmental Compatibility Problem
1
1
Thermal Decomposition of Device
1
1
Application Program Problem: Dose Calculation Error
1
1
Gas/Air Leak
1
1
Charred
1
1
Patient Device Interaction Problem
1
1
Defective Device
1
1
Patient Data Problem
1
1
Electrical Power Problem
1
1
Application Program Problem
1
1
Mechanical Problem
1
1
Output Problem
1
1
Fumes or Vapors
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
42
42
No Patient Involvement
24
24
No Consequences Or Impact To Patient
16
16
No Clinical Signs, Symptoms or Conditions
7
7
No Information
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Fatigue
1
1
Red Eye(s)
1
1
Dizziness
1
1
Malaise
1
1
Irritation
1
1
Injury
1
1
Insufficient Information
1
1
Hypoglycemia
1
1
Fainting
1
1
Thromboembolism
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
NDDd Medical Technologies, Inc.
II
Dec-03-2019
2
Shape Medical Systems, Inc
II
Feb-05-2015
-
-