FDA.reportPublic FDA data

MGC Diagnostics

Primary DI
B3687620420030
Brand
MGC Diagnostics
Company
MEDICAL GRAPHICS CORPORATION
Model
762042-003
Catalog number
800704-003
Device description
CPFS/D-USB
Published
2017-01-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K871711000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K871711000MEDICAL GRAPHICS DESKTOP DIAGNOSTIC SYSTEMMedical Graphics Corp.1987-09-25BZM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
800704003PackageHIBCC1In Commercial Distribution
B3687620420030PrimaryHIBCC0

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
094045622
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810016250555Medical Graphics147999-0042023-07-18
00810016250579Medical Graphics147999-5022023-07-18
00810016250616Medical Graphics536018-001 2023-06-14
00810016250340MGC Diagnostics762042-003800704-0032019-02-22
00810016250357MGC Diagnostics762042-904800704-9042019-02-22
00810016250364MGC Diagnostics762042-905800704-9052019-02-22
B3687620429040MGC Diagnostics762042-904800704-9042018-06-18
B3687620429050MGC Diagnostics762042-905800704-9052018-06-18
B368700023905MGC Diagnostics700023-905700023-9052016-09-09
B3687000239060MGC Diagnostics700023-9062018-06-18
B368800810001MGC Diagnostics800810-001800810-0012016-09-09
B368800810011MGC Diagnostics800810-011800810-0112016-09-09
B3688008100210MGC Diagnostics800810-0212018-06-18
B3688008100310MGC Diganostics800810-0312018-06-18
B368800820001MGC Diagnostics800820-001800820-0012016-09-07
B368800820011MGC Diagnostics800820-011800820-0112016-09-09
B3688008200210MGC Diagnostics800820-0212018-06-18
B3688008200310MGC Diagnostics800820-0312018-06-18
B368800830001MGC Diagnostics800830-001800830-0012016-09-09
B368800830011MGC Diagnostics800830-011800830-0112016-09-09

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