FDA.reportPublic FDA data

Resmon PRO FULL

Primary DI
08050612840008
Brand
Resmon PRO FULL
Company
RESTECH SRL
Model
RT1100
Device description
Resmon PRO FULL is a device for the measurement of the respiratory system impedance based on the Forced Oscillation Technique (FOT).
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZGSpirometer, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZGSpirometer, DiagnosticAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152585000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152585000Resmon PRO FULLMedical Graphics Corp.2016-06-24PNV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08050612840008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08050612840008080506128400088050612840008

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary function analysis system, paediatricA computerized instrument designed to assess lung volume, flow, and mechanical parameters (including airway compliance and resistance) in young children and infants. It is different from an adult version in absolute dimensions and in the special procedures required for adaption to the pediatric patient (e.g., use of a small constant-volume chamber in which the infant reclines for plethysmography, use of a pressure jacket to obtain forced exhalation); also, parameters that require subject cooperation (e.g., vital capacity, forced expiratory volume) can't be determined. The device is used for pulmonary function testing in diagnostic studies and for evaluation of diseases and chest deformities.

Contacts#

Phone, Email table
PhoneEmail
9999999999support@restech.it

Regulatory Flags#

DUNS number
431062628
Device count
1
Serial number
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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