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FDA 510(k)

AS/3 PRESSURE TEMPERATURE MODULE, M-PT

K-Number: K943457 · 1994-07-27

ApplicantDatex Division Instrumentarium Corp.
Decision Date1994-07-27
Product CodeDSK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AS/3 PRESSURE TEMPERATURE MODULE, M-PT is the device name listed in this FDA 510(k) record. The listed applicant is Datex Division Instrumentarium Corp.. It received FDA 510(k) clearance on 1994-07-27 under 510(k) number K943457. The device is classified under product code DSK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AS/3 PRESSURE TEMPERATURE MODULE, M-PT?

AS/3 PRESSURE TEMPERATURE MODULE, M-PT is a medical device that received FDA 510(k) clearance on 1994-07-27. The listed applicant is Datex Division Instrumentarium Corp.. The 510(k) number is K943457.

When did AS/3 PRESSURE TEMPERATURE MODULE, M-PT receive FDA 510(k) clearance?

AS/3 PRESSURE TEMPERATURE MODULE, M-PT received FDA 510(k) clearance on 1994-07-27, under 510(k) number K943457.

Who is the listed applicant for AS/3 PRESSURE TEMPERATURE MODULE, M-PT?

The FDA 510(k) record lists Datex Division Instrumentarium Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AS/3 PRESSURE TEMPERATURE MODULE, M-PT?

The FDA product code for AS/3 PRESSURE TEMPERATURE MODULE, M-PT is DSK.

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Other records listing Datex Division Instrumentarium Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K953175AS/3 ESTPR MODULEK961247AS/3 LIGHT MONITORK943458AS/3 AIRWAY MODULEK945234AS/3 MEMORY MODULE, M0MEMK933156DATEX AS/3 PATIENT MONITORK933285DATEX AS/3 TM ANAESTHESIA MONITOR

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Related Devices (Code: DSK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231586Endophys Blood Pressure Monitor model BPM-30Endophys Technologies, LLCK160945Endophys Blood Pressure MonitorEndophys Holdings, LLCK080670MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEMAtcor MedicalK070795SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEMAtcor Medical Pty, Ltd.K033738MONITORING SYSTEM, MODEL ARGUS PB-2200Schiller AGK021517ABP FOR WINDOWSRozinn Electronics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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