FDA.reportPublic FDA data

TrueOne 2400

Primary DI
B687MMS240005
Brand
TrueOne 2400
Company
PARVOMEDICS, INCORPORATED
Model
MMS-2400
Device description
The TrueOne® 2400 is a compact, integrated metabolic measurement system for cardiopulmonary stress testing, indirect calorimetry, and maximal O2 consumption measurement.
Published
2018-09-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BZCCalculator, Pulmonary Function Data

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZCCalculator, Pulmonary Function DataAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K941843000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K941843000MMS-2400Parvo Medics, Inc.1995-06-16BZC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B687MMS240005PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic spirometerA mains electricity (AC-powered) device designed to measure several or all respiratory-gas volume and flow parameters needed to evaluate basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF)]. It is an instrument used in a clinical setting with a mouthpiece and tube attached to a computerized unit to process the data from patient ventilatory efforts, volume and/or flow sensors, a display, and usually a graph recorder. The data are compared to standardized values or the patient's former values to help identify or evaluate chronic pulmonary disorders such as asthma, emphysema, or bronchitis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
043063893
Device count
1
Serial number
true

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