CARDIOCAP(TM) DR-104 REPORTER— 510(k) K885058

Name: FDA 510(k) clearance K885058
Creator: U.S. Food and Drug Administration
Published: 1989-07-14

Substantially Equivalent

Datex Division Instrumentarium Corp.

FDA 510(k) clearance K885058 for CARDIOCAP(TM) DR-104 REPORTER, Substantially Equivalent on 1989-07-14. Applicant: Datex Division Instrumentarium Corp.. Device class: 1.

Clearance details

Applicant: Datex Division Instrumentarium Corp.
Product code: Code DSF
Device class: Class 1
Regulation: 21 CFR 870.2810
Advisory panel: Cardiovascular
Date received: 1988-12-07
Decision date: 1989-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, Finland, FI

Download summary PDF View on FDA.gov ↗

Recent devices under product code DSF

view all

K910871 — EDENTEC DIGITAL CHARTER MODEL 37101991-08-29
K912929 — DASH IV1991-08-13
K905856 — MODEL 556 MONITOR1991-01-11
K902586 — GRI LASERGRAPH(TM) ECG PAPER1990-06-22
K902230 — COLORADO COLOR IMAGING RECORDER1990-06-19

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.