MEDICAL GRAPHICS CORPORATION

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Computer, Oxygen-Uptake (BZL) (5) Calculator, Pulmonary Function Interpretor (Diagnostic) (BZM) (2) Spirometer, Diagnostic (BZG) (2) Calculator, Pulmonary Function Data (BZC) (1)

Premarket Exempt

Yes No

Clear

MGC Diagnostics - B3685367230010 Catalog Number : 536723-001

Device Description : FILTER KIT 2

Device Class : 2

Duns Number: 094045622

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

MGC Diagnostics - B3685367230040 Catalog Number : 536723-004

Device Description : FILTER KIT 4

Device Class : 2

Duns Number: 094045622

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

MGC Diagnostics - B368700023905 Catalog Number : 700023-905

Device Description : Express CCM

Device Class : 2

Duns Number: 094045622

Premarket Exempt : No

Product Code : BZL

Prescription Use : Yes

Device Count : 1

MGC Diagnostics - B3687000239060 Catalog Number :

Device Description : Express Series CCM

Device Class : 2

Duns Number: 094045622

Premarket Exempt : No

Product Code : BZL

Prescription Use : Yes

Device Count : 1

MGC Diagnostics - B3687620420030 Catalog Number : 800704-003

Device Description : CPFS/D-USB

Device Class :

Duns Number: 094045622

Premarket Exempt : No

Product Code : BZC

Prescription Use : Yes

Device Count : 1

MGC Diagnostics - B3687620429040 Catalog Number : 800704-904

Device Description : CPFS/D-USB

Device Class : 2

Duns Number: 094045622

Premarket Exempt : No

Product Code : BZM

Prescription Use : Yes

Device Count : 1

MGC Diagnostics - B3687620429050 Catalog Number : 800704-905

Device Description : CPFS/D-USB

Device Class : 2

Duns Number: 094045622

Premarket Exempt : No

Product Code : BZM

Prescription Use : Yes

Device Count : 1

MGC Diagnostics - B368800810001 Catalog Number : 800810-001

Device Description : Ultima System CPX

Device Class : 2

Duns Number: 094045622

Premarket Exempt : No

Product Code : BZL

Prescription Use : Yes

Device Count : 1

MGC Diagnostics - B368800810011 Catalog Number : 800810-011

Device Description : Ultima System CPX - 120V UPS

Device Class : 2

Duns Number: 094045622

Premarket Exempt : No

Product Code : BZL

Prescription Use : Yes

Device Count : 1

MGC Diagnostics - B3688008100210 Catalog Number :

Device Description : Ultima System CPX

Device Class : 2

Duns Number: 094045622

Premarket Exempt : No

Product Code : BZL

Prescription Use : Yes

Device Count : 1

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