FDA.reportPublic FDA data

FUTUREMED

Primary DI
00853452007024
Brand
FUTUREMED
Company
FUTUREMED AMERICA, INC.
Model
SpiroVision
Device description
SPIROVISION PC BASED SPIROMETER
Published
2017-10-24
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
BTYCalculator, Predicted Values, Pulmonary Function
BZCCalculator, Pulmonary Function Data
BZGSpirometer, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTYCalculator, Predicted Values, Pulmonary FunctionAnesthesiology2
BZCCalculator, Pulmonary Function DataAnesthesiology2
BZGSpirometer, DiagnosticAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020745000
K953948000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020745000COSMED MICROQUARKCosmed Srl2003-01-02BTY
K953948000SPIROVISION SV-III PC BASED SPIROMETER KIT MICROFuturemed America, Inc.1996-06-25BZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853452007024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853452007024008534520070248534520070240853452007024

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

Contacts#

Phone, Email table
PhoneEmail
818-830-2500info@futuremed.com

Regulatory Flags#

DUNS number
195929658
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853452007017FUTUREMEDDiscovery-22017-10-24
00853452007178FUTUREMED39NA Oval PFT Filter39NAE-XXX2017-10-24
00853452007307FUTUREMEDSize 2 Oval PFT Filter39XXX-02E2017-10-24
00853452007406FUTUREMEDSize 3 PFT Filter39XXX-032017-10-24
00853452007185FUTUREMED39NA Oval PFT Filter39NAE-XXX2017-10-24
00853452007208FUTUREMEDSize 1 PFT Filter39298-Bulk2017-10-24
00853452007314FUTUREMEDSize 2 Oval PFT Filter39XXX-02E2017-10-24
00853452007413FUTUREMEDSize 3 PFT Filter39XXX-032017-10-24

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Primary DI, Brand, Company table
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