BIOMA 2000— 510(k) K862808

Substantially Equivalent

E.B.S., Inc.

FDA 510(k) clearance K862808 for BIOMA 2000, Substantially Equivalent on 1987-02-19. Applicant: E.B.S., Inc.. Device class: 2.

Clearance details

Applicant: E.B.S., Inc.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1986-07-23
Decision date: 1987-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code DXG

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 E.B.S., Inc.

K880036 — BIOMA 50001988-03-07
K872370 — BIOMA 35001987-12-07

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