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FDA 510(k)

PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM

K-Number: K953893 · 1997-11-04

ApplicantBiomedical Sensors, Inc.
Decision Date1997-11-04
Product CodeCCC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Sensors, Inc.. It received FDA 510(k) clearance on 1997-11-04 under 510(k) number K953893. The device is classified under product code CCC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM?

PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1997-11-04. The listed applicant is Biomedical Sensors, Inc.. The 510(k) number is K953893.

When did PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM receive FDA 510(k) clearance?

PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM received FDA 510(k) clearance on 1997-11-04, under 510(k) number K953893.

Who is the listed applicant for PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM?

The FDA 510(k) record lists Biomedical Sensors, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM?

The FDA product code for PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM is CCC.

Related Clinical Trials

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.

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Other records listing Biomedical Sensors, Inc. 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.

K862069CARDIOMET 4000 GAS MONITORING SYSTEMS

Related Devices (Code: CCC)

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.

K071165ISCALERT SENSOR SYSTEMAlertis Medical ASK983198TRENDCARE CALIBRATOR MODEL SCU 7007Diametrics Medical, Ltd.K972314PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEMDiametrics Medical, Ltd.K961790POINT-OF-CARE BLOOD GAS MONITOR SYSTEMOptical Sensors, Inc.K963935OLYMPUS CRITICAL CARE MONITORING SYSTEMOptical Sensors, Inc.K951094POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEMOptical Sensors, Inc.

Official Source

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

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