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FDA 510(k)

DELTATRAC(TM) METABOLIC MONITOR

K-Number: K864603 · 1987-03-17

ApplicantDatex Division Instrumentarium Corp.
Decision Date1987-03-17
Product CodeBZL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DELTATRAC(TM) METABOLIC MONITOR 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 1987-03-17 under 510(k) number K864603. The device is classified under product code BZL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DELTATRAC(TM) METABOLIC MONITOR?

DELTATRAC(TM) METABOLIC MONITOR is a medical device that received FDA 510(k) clearance on 1987-03-17. The listed applicant is Datex Division Instrumentarium Corp.. The 510(k) number is K864603.

When did DELTATRAC(TM) METABOLIC MONITOR receive FDA 510(k) clearance?

DELTATRAC(TM) METABOLIC MONITOR received FDA 510(k) clearance on 1987-03-17, under 510(k) number K864603.

Who is the listed applicant for DELTATRAC(TM) METABOLIC MONITOR?

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 DELTATRAC(TM) METABOLIC MONITOR?

The FDA product code for DELTATRAC(TM) METABOLIC MONITOR is BZL.

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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: BZL)

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.

K200076Breezing MedTf Health Co.K190561NICU V'02Cosmed Nordic ApsK110810ANASCIENT BREATH MONITORInvoy Technologies, LLCK093080METAPHOR METABOLIC MONITORTreymed, Inc.K071533FITMATE SERIESCosmed SrlK070858EXPRESS SERIESMedical Graphics Corp.

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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