Osypka Medical GmbH

Address:Albert-Einstein-Strasse 3,BERLIN,DE

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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

Pulse-Generator, Pacemaker, External (DTE) (5) Plethysmograph, Impedance (DSB) (1) Tester, Pacemaker Electrode Function (DTA) (1)

Premarket Exempt

Clear

CARDIOTRONIC - 04260451441012 Catalog Number : 2001

Device Description : PACE 101 External Single-Chamber Pacemaker (with clamping terminals)

Device Class : 2

Duns Number: 317157048

Premarket Exempt : No

Product Code : DTE

Prescription Use : No

Device Count : 1

CARDIOTRONIC - 04260451441029 Catalog Number : 2002

Device Description : PACE 203 External Dual-Chamber Pacemaker (with clamping terminals)

Device Class : 2

Duns Number: 317157048

Premarket Exempt : No

Product Code : DTE

Prescription Use : No

Device Count : 1

CARDIOTRONIC - 04260451441043 Catalog Number :

Device Description : ICON Non-invasive Hemodynamic Cardiometer

Device Class : 2

Duns Number: 317157048

Premarket Exempt : No

Product Code : DSB

Prescription Use : No

Device Count : 1

CARDIOTRONIC - 04260451441050 Catalog Number : 2004

Device Description : PACE 101 External Single-Chamber Pacemaker (with bipolar terminals)

Device Class : 2

Duns Number: 317157048

Premarket Exempt : No

Product Code : DTE

Prescription Use : No

Device Count : 1

CARDIOTRONIC - 04260451441067 Catalog Number : 2003

Device Description : PACE 203 External Dual-Chamber Pacemaker (with bipolar terminals)

Device Class : 2

Duns Number: 317157048

Premarket Exempt : No

Product Code : DTE

Prescription Use : No

Device Count : 1

Osypka Medical - 04260451441173 Catalog Number :

Device Description : PSA 200 Pacing System Analyzer

Device Class : 2

Duns Number: 317157048

Premarket Exempt : No

Product Code : DTE, DTA

Prescription Use : No

Device Count : 1

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