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FDA 510(k)

AS/3 AIRWAY MODULE

K-Number: K943458 · 1995-02-14

ApplicantDatex Division Instrumentarium Corp.
Decision Date1995-02-14
Product CodeCBS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AS/3 AIRWAY 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 1995-02-14 under 510(k) number K943458. The device is classified under product code CBS. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AS/3 AIRWAY MODULE?

AS/3 AIRWAY MODULE is a medical device that received FDA 510(k) clearance on 1995-02-14. The listed applicant is Datex Division Instrumentarium Corp.. The 510(k) number is K943458.

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

AS/3 AIRWAY MODULE received FDA 510(k) clearance on 1995-02-14, under 510(k) number K943458.

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

The FDA product code for AS/3 AIRWAY MODULE is CBS.

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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 MONITORK945234AS/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: CBS)

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.

K974903GAS MODULE II, MODEL 0998-00-0143Datascope Corp.K953795VITALMAX 4100Pace Tech, Inc.K960490AS/3 COMPACT AIRWAY MODULE M-CAIOVDatex Medical Instrumentation, Inc.K951366RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18)Riken Keiki Co., Ltd.K950101RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITORMarquette Electronics, Inc.K942737POET IQ WITH FIVE AGENT CAPABILITYCriticare Systems, 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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