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FDA 510(k)

AS/3 ESTPR MODULE

K-Number: K953175 · 1997-02-06

ApplicantDatex Division Instrumentarium Corp.
Decision Date1997-02-06
Product CodeMLD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AS/3 ESTPR MODULE 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 1997-02-06 under 510(k) number K953175. The device is classified under product code MLD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AS/3 ESTPR MODULE?

AS/3 ESTPR MODULE is a medical device that received FDA 510(k) clearance on 1997-02-06. The listed applicant is Datex Division Instrumentarium Corp.. The 510(k) number is K953175.

When did AS/3 ESTPR MODULE receive FDA 510(k) clearance?

AS/3 ESTPR MODULE received FDA 510(k) clearance on 1997-02-06, under 510(k) number K953175.

Who is the listed applicant for AS/3 ESTPR MODULE?

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 ESTPR MODULE?

The FDA product code for AS/3 ESTPR MODULE is MLD.

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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.

K961247AS/3 LIGHT MONITORK943458AS/3 AIRWAY MODULEK945234AS/3 MEMORY MODULE, M0MEMK933156DATEX AS/3 PATIENT MONITORK933285DATEX AS/3 TM ANAESTHESIA MONITORK943456AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT

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Related Devices (Code: MLD)

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.

K101602VITAL SIGNS MONITORCriticare Systems, Inc.K080461STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0Philips Medical SystemsK022740DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWAREDatex-OhmedaK012837MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIESDatex-OhmedaK002105SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSISSiemens Medical Solutions USA, Inc.K992323DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIESDatex-Ohmeda, 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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