SERVO NEBULIZER 945 SIEMENS-ELEMA AB— 510(k) K871293

Name: FDA 510(k) clearance K871293
Creator: U.S. Food and Drug Administration
Published: 1987-05-08

Substantially Equivalent

Siemens Elema AB

FDA 510(k) clearance K871293 for SERVO NEBULIZER 945 SIEMENS-ELEMA AB, Substantially Equivalent on 1987-05-08. Applicant: Siemens Elema AB. Device class: 2.

Clearance details

Applicant: Siemens Elema AB
Product code: Code CAF
Device class: Class 2
Regulation: 21 CFR 868.5630
Advisory panel: Anesthesiology
Date received: 1987-03-31
Decision date: 1987-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schaumburg, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CAF

view all

K260270 — FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)2026-06-02
K251572 — eRapid with eTrack System2025-12-19
K251659 — Mesh Nebulizer (H6)2025-11-14
K244035 — Portable mesh nebulizer (JM821)2025-09-19
K243468 — Compressor Nebulizer (4 models)2025-07-02

More clearances from Siemens Elema AB

view all

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 CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

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.