OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR— 510(k) K844277

Name: FDA 510(k) clearance K844277
Creator: U.S. Food and Drug Administration
Published: 1985-02-15

Substantially Equivalent

Omikron Scientific, Ltd.

FDA 510(k) clearance K844277 for OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR, Substantially Equivalent on 1985-02-15. Applicant: Omikron Scientific, Ltd.. Device class: 2.

Clearance details

Applicant: Omikron Scientific, Ltd.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1984-11-05
Decision date: 1985-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Israel, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code DXG

view all

K253092 — Argos Infinity (Rev. 1.0)2026-02-13
K251275 — VitalStream ART Connect; VitalStream-Hemo2025-09-26
K232048 — Cogent Hemodynamic Monitoring System; Cogent HMS2023-12-20
K212529 — Hypotension Decision Assist Model HDA-OR22021-11-23
K192169 — PulsioFlex Monitoring System with ProAQT Sensor2020-04-30

More clearances from Omikron Scientific, Ltd.

view all

K904445 — OMIBAND1991-03-06
K874480 — MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM)1988-02-22
K840748 — LITHIUM PACEMAKER 811-811L & 811XL1984-08-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.