SMU 611 VERS. 2.0 INCLUDING PRESSNI,DILU,SAT-MOD.— 510(k) K903900

Name: FDA 510(k) clearance K903900
Creator: U.S. Food and Drug Administration
Published: 1991-01-08

Substantially Equivalent

Ppg Hellige B.V.

FDA 510(k) clearance K903900 for SMU 611 VERS. 2.0 INCLUDING PRESSNI,DILU,SAT-MOD., Substantially Equivalent on 1991-01-08. Applicant: Ppg Hellige B.V.. Device class: 2.

Clearance details

Applicant: Ppg Hellige B.V.
Product code: Code DSK
Device class: Class 2
Regulation: 21 CFR 870.1110
Advisory panel: Cardiovascular
Date received: 1990-08-23
Decision date: 1991-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Germany, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code DSK

view all

K231586 — Endophys Blood Pressure Monitor model BPM-302023-11-03
K160945 — Endophys Blood Pressure Monitor2016-09-26
K152582 — CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box2015-12-03
K141615 — ENDOPHYS BLOOD PRESSURE MONITOR2015-01-07
K080670 — MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM2008-04-23

More clearances from Ppg Hellige B.V.

view all

K921666 — CARDIAC THERAPHY SYSTEM SCP 9001993-09-23
K903917 — COMPACT MONITOR SMK 210,211,230,231,2401991-01-18

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