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)

PERFUSION MONITOR

K-Number: K900860 · 1990-08-14

ApplicantCardio Metrics, Inc.
Decision Date1990-08-14
Product CodeDTY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERFUSION MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Metrics, Inc.. It received FDA 510(k) clearance on 1990-08-14 under 510(k) number K900860. The device is classified under product code DTY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERFUSION MONITOR?

PERFUSION MONITOR is a medical device that received FDA 510(k) clearance on 1990-08-14. The listed applicant is Cardio Metrics, Inc.. The 510(k) number is K900860.

When did PERFUSION MONITOR receive FDA 510(k) clearance?

PERFUSION MONITOR received FDA 510(k) clearance on 1990-08-14, under 510(k) number K900860.

Who is the listed applicant for PERFUSION MONITOR?

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

What is the FDA product code for PERFUSION MONITOR?

The FDA product code for PERFUSION MONITOR is DTY.

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 Cardio Metrics, 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.

K972762CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRESK965140CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEMK951567CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIREK961777ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404K955551CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404K954913CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION)

View all 23 devices →

Related Devices (Code: DTY)

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.

K093650BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEMMedtronic, Inc.K963698CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4International Biophysics Corp.K954501BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEMMedtronic Bio-Medicus, Inc.K902654CDI (TM) SYSTEM 100 MONITORING SYSTEM3M Health Care, Ltd.K864703MODIFIED GAS-STAT(TM) MONITORING SYSTEMCardiovascular Devices, Inc.K840749GAST STAT MONITORING SYSTEMCardiovascular Devices, 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.

↑