SPECTRAMED MODEL SP1455 HEMOPRO2 SYSTEM— 510(k) K865101

Name: FDA 510(k) clearance K865101
Creator: U.S. Food and Drug Administration
Published: 1987-04-20

Substantially Equivalent

Spectramed, Inc.

FDA 510(k) clearance K865101 for SPECTRAMED MODEL SP1455 HEMOPRO2 SYSTEM, Substantially Equivalent on 1987-04-20. Applicant: Spectramed, Inc.. Device class: 2.

Clearance details

Applicant: Spectramed, Inc.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1986-12-30
Decision date: 1987-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis Park, MN, US

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 Spectramed, Inc.

view all

K896122 — AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED1990-01-19
K892941 — CCO SYSTEM MODEL SP1467,SP5567,SP62671989-11-06
K895323 — MODEL DT-BAL, BALANCE SAVER1989-10-24
K894362 — MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP1989-08-15
K881857 — AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU.1989-02-01

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