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FDA 510(k)

SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE

K-Number: K931185 · 1993-10-21

ApplicantOptical Sensors, Inc.
Decision Date1993-10-21
Product CodeCCC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE is the device name listed in this FDA 510(k) record. The listed applicant is Optical Sensors, Inc.. It received FDA 510(k) clearance on 1993-10-21 under 510(k) number K931185. 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 SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE?

SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE is a medical device that received FDA 510(k) clearance on 1993-10-21. The listed applicant is Optical Sensors, Inc.. The 510(k) number is K931185.

When did SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE receive FDA 510(k) clearance?

SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE received FDA 510(k) clearance on 1993-10-21, under 510(k) number K931185.

Who is the listed applicant for SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE?

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

What is the FDA product code for SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE?

The FDA product code for SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE is CCC.

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Other records listing Optical 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.

K040654SENSILASE PAD 3000K010795CAPNOPROBE SL, MODEL 2000K984579CAPNO PROBE AK961790POINT-OF-CARE BLOOD GAS MONITOR SYSTEMK963935OLYMPUS CRITICAL CARE MONITORING SYSTEMK951094POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM

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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.K953893PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEMBiomedical Sensors, Inc.K961790POINT-OF-CARE BLOOD GAS MONITOR SYSTEMOptical Sensors, Inc.K963935OLYMPUS CRITICAL CARE MONITORING SYSTEMOptical Sensors, 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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