Who is the manufacturer of AS/3 LIGHT MONITOR?

Datex Division Instrumentarium Corp. filed the 510(k) submission for AS/3 LIGHT MONITOR (K961247).

What is the FDA product code for AS/3 LIGHT MONITOR?

DPS. It is classified under 21 CFR 870.2340 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for AS/3 LIGHT MONITOR?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like AS/3 LIGHT MONITOR?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

AS/3 LIGHT MONITOR

K961247 · Datex Division Instrumentarium Corp. · DPS · Oct 23, 1996 · Cardiovascular

Device Facts

Record ID	K961247
Device Name	AS/3 LIGHT MONITOR
Applicant	Datex Division Instrumentarium Corp.
Product Code	DPS · Cardiovascular
Decision Date	Oct 23, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2340
Device Class	Class 2

Intended Use

AS/3 Light Monitor is intended for stationary and mobile indoor monitoring of a patient’s vital signs.

Device Story

Portable patient monitor; measures ECG, invasive blood pressure, SpO2, temperature, and NIBP. Configurations: LM (ECG, SpO2, 1 temp, NIBP) or LMP (ECG, SpO2, 2 invasive pressures, 2 temps, NIBP). Operates on battery or mains power. Used in clinical settings for continuous vital sign monitoring. Provides real-time physiological data to clinicians to support patient assessment and clinical decision-making.

Clinical Evidence

Bench testing only. Device tested against established specifications of the predicate AS/3 Compact Monitor to confirm equivalent performance.

Technological Characteristics

Portable patient monitor; measures ECG, invasive/non-invasive blood pressure, SpO2, and temperature. Powered by battery or mains. Utilizes same measurement techniques and algorithms as predicate AS/3 Compact Monitor.

Indications for Use

Indicated for patients requiring stationary or mobile indoor monitoring of vital signs, including ECG, invasive blood pressure, SpO2, temperature, and non-invasive blood pressure (NIBP).

Regulatory Classification

Identification

An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

Predicate Devices

Datex AS/3™ Compact Monitor with ESTP and NIBP modules

Related Devices

K221879 — Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 · Caf Medical Solutions, Inc. · Aug 10, 2022
K082008 — BIONET BM3PLUS PATIENT MONITOR · Bionet Co., Ltd. · Dec 11, 2008
K080157 — DASH 2500 PATIENT MONITOR · Ge Medical Systems Information Technologies · Mar 24, 2008
K981378 — DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1 · Datex-Engstrom, Inc. · Nov 3, 1998
K131818 — VITAL SIGNS MONITOR · Edan Instruments, Inc. · Aug 30, 2013

Submission Summary (Full Text)

{0} Datex K961247 510(k) SUMMARY OCT 23 1996 27 March, 1996 Datex-Engström Division Instrumentarium Corp. P.O. Box 446 FIN-00101 Helsinki Finland Tel: +358 0 39411 Fax: +358 0 1463310 Contact person: Rauno Ruoho ## PRODUCT NAMES Device name: AS/3™ Light Monitor Common name: Hemodynamic measurement device ## DESCRIPTION OF THE DEVICE AS/3 Light Monitor is a portable patient monitor which measures ECG, 2 invasive blood pressures, oxygen saturation SpO₂, 2 temperatures and non-invasive blood pressure NIBP. The measurement technics are similar to the AS/3 Compact Monitor with ESTP module and NIBP module. See section 3 for details. AS/3 Light Monitor will be available in two following configurations: - LM which measures ECG, SpO₂, 1 temperature and NIBP - LMP which measures ECG, SpO₂, 2 invasive blood pressures, 2 temperatures and NIBP. The monitor can be driven with battery or with mains power. ## INTENDED USE AS/3 Light Monitor is intended for stationary and mobile indoor monitoring of a patient’s vital signs. ## SUBSTANTIAL EQUIVALENCE In terms of overall functions and parameters measured, the AS/3™ Light Monitor is substantially equivalent in safety and effectiveness to Datex AS/3™ Compact Monitor with ESTP and NIBP modules. {1} Measurement parameters are the same as in Datex AS/3™ Compact Monitor with ESTP and NIBP modules. Measurement units are redesigned, but measurement technics and algorithms are the same. The specifications of the monitors were compared and AS/3™ Light Monitor was tested against the specifications. The results showed that AS/3™ Light Monitor is substantially equivalent with AS/3™ Compact Monitor.