MASTER PROGRAM FLOW & PRESSURE CO2 & LUNG MONITOR— 510(k) K861707

Name: FDA 510(k) clearance K861707
Creator: U.S. Food and Drug Administration
Published: 1986-06-19

Substantially Equivalent

Siemens Elema AB

FDA 510(k) clearance K861707 for MASTER PROGRAM FLOW & PRESSURE CO2 & LUNG MONITOR, Substantially Equivalent on 1986-06-19. Applicant: Siemens Elema AB. Device class: 2.

Clearance details

Applicant: Siemens Elema AB
Product code: Code CBK
Device class: Class 2
Regulation: 21 CFR 868.5895
Advisory panel: Anesthesiology
Date received: 1986-05-05
Decision date: 1986-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schaumburg, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Siemens Elema AB

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K023354 — COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E2003-09-05
K010923 — KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E2002-01-23
K010925 — SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E2001-12-18
K002137 — CATHCOR DESKTOP2000-10-05
K001315 — MODIFICATION TO KION ANESTHESIA SYSTEM2000-05-26

Adverse events under product code CBK

product code CBK

Death: 736
Injury: 3,628
Malfunction: 98,786
Other: 4
Total: 103,154

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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