TYPE 9140 (SYSTEM ATHENA)

FDA 510(k)

FDA Class 2 ·Cardiovascular

TYPE 9266 SAO2 SYSTEM ATHENA

FDA 510(k)

FDA Class 2 ·Cardiovascular

9293/1 INTERFACE MODULE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA

FDA 510(k)

FDA Class 2 ·General Hospital

TYPE 9292 INTERFACE CAPNOGRAPH

FDA 510(k)

FDA Class 2 ·Anesthesiology

TYPE 9040/NEO

FDA 510(k)

FDA Class 2 ·Cardiovascular

CALIBRATION KIT

FDA 510(k)

FDA Class 1 ·Anesthesiology

AMENDMENT ULTRASOUND SCANNER TYPE 1842/1846/1849

FDA 510(k)

FDA Class 2 ·Radiology

LKB Vertriebs Ges.m.b.H

Importer

🇦🇹 Austria·1 Manufacturer

Kit, Typing, Hla-Dqb

FDA classification

FDA Class 2 ·Kit, Typing, Hla-Dqb

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE(R) AND CAPSURE(R)SP LEADS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE(R) AND CAPSURE(R) SP PACING LEADS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·SWEET TIP RX STEROID ELUTING LEAD

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·FLEXTEND BIPOLAR, STEROID ELUTING, EXTENDABLE/ RETRACTABLE PACING LEAD

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·THINLINE/FINELINE

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·SUREFIX TM MODEL 5072 LEAD

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·PASSIVE PLUS DX ENDOCARDIAL, STEROID ELUTING, PASSIVE FIXATION PACING LEADS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·PHILOS FAMILY OF PULSE GENERATORS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP