3050 Diascope NT Patient Monitor

FDA 510(k) K942196 · S & W Medico Teknik A/S

Substantially Equivalent

510(k) numberK942196

Submission

Device name
3050 Diascope NT Patient Monitor
Applicant
S & W Medico Teknik A/S
Albertslund, DK
Received
May 4, 1994
Decision date
June 28, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DSI – Detector And Alarm, Arrhythmia
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1025
Specialty
Cardiovascular

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Questions and answers

When was 3050 Diascope NT Patient Monitor cleared by the FDA?

3050 Diascope NT Patient Monitor (K942196) received a 510(k) decision of Substantially Equivalent on June 28, 1995, 420 days after the submission was received.

What is the product code of K942196?

The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.