Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OLYMPUS CRITICAL CARE MONITORING SYSTEM

K-Number: K963935 · 1997-01-23

ApplicantOptical Sensors, Inc.
Decision Date1997-01-23
Product CodeCCC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OLYMPUS CRITICAL CARE MONITORING SYSTEM 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 1997-01-23 under 510(k) number K963935. 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 OLYMPUS CRITICAL CARE MONITORING SYSTEM?

OLYMPUS CRITICAL CARE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1997-01-23. The listed applicant is Optical Sensors, Inc.. The 510(k) number is K963935.

When did OLYMPUS CRITICAL CARE MONITORING SYSTEM receive FDA 510(k) clearance?

OLYMPUS CRITICAL CARE MONITORING SYSTEM received FDA 510(k) clearance on 1997-01-23, under 510(k) number K963935.

Who is the listed applicant for OLYMPUS CRITICAL CARE MONITORING SYSTEM?

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 OLYMPUS CRITICAL CARE MONITORING SYSTEM?

The FDA product code for OLYMPUS CRITICAL CARE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SYSTEMK951094POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEMK931185SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE

View all 7 devices →

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.K951094POINT-OF-CARE ARTERIAL BLOOD GAS 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.

↑