NORMAC ANESTHETIC AGENT MONITOR— 510(k) K832113

Name: FDA 510(k) clearance K832113
Creator: U.S. Food and Drug Administration
Published: 1983-09-12

Substantially Equivalent

Datex Division Instrumentarium Corp.

FDA 510(k) clearance K832113 for NORMAC ANESTHETIC AGENT MONITOR, Substantially Equivalent on 1983-09-12. Applicant: Datex Division Instrumentarium Corp.. Device class: 2.

Clearance details

Applicant: Datex Division Instrumentarium Corp.
Product code: Code CBS
Device class: Class 2
Regulation: 21 CFR 868.1620
Advisory panel: Anesthesiology
Date received: 1983-06-30
Decision date: 1983-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki 10 Finland, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CBS

view all

K974903 — GAS MODULE II, MODEL 0998-00-01431998-03-13
K953795 — VITALMAX 41001996-07-01
K960490 — AS/3 COMPACT AIRWAY MODULE M-CAIOV1996-05-03
K951366 — RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18)1995-08-02
K950101 — RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITOR1995-03-21

More clearances from Datex Division Instrumentarium Corp.

view all

K953175 — AS/3 ESTPR MODULE1997-02-06
K961247 — AS/3 LIGHT MONITOR1996-10-23
K943458 — AS/3 AIRWAY MODULE1995-02-14
K945234 — AS/3 MEMORY MODULE, M0MEM1995-01-27
K933156 — DATEX AS/3 PATIENT MONITOR1994-12-30

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