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)

MONITOR, PO2, INTRAVASCULAR

K-Number: K781271 · 1978-10-12

ApplicantRoche Medical Electronics, Inc.
Decision Date1978-10-12
Product CodeCCE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MONITOR, PO2, INTRAVASCULAR is the device name listed in this FDA 510(k) record. The listed applicant is Roche Medical Electronics, Inc.. It received FDA 510(k) clearance on 1978-10-12 under 510(k) number K781271. The device is classified under product code CCE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONITOR, PO2, INTRAVASCULAR?

MONITOR, PO2, INTRAVASCULAR is a medical device that received FDA 510(k) clearance on 1978-10-12. The listed applicant is Roche Medical Electronics, Inc.. The 510(k) number is K781271.

When did MONITOR, PO2, INTRAVASCULAR receive FDA 510(k) clearance?

MONITOR, PO2, INTRAVASCULAR received FDA 510(k) clearance on 1978-10-12, under 510(k) number K781271.

Who is the listed applicant for MONITOR, PO2, INTRAVASCULAR?

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

What is the FDA product code for MONITOR, PO2, INTRAVASCULAR?

The FDA product code for MONITOR, PO2, INTRAVASCULAR is CCE.

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 Roche Medical Electronics, 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.

K791559ROCHE SENSOR ADAPTORK791038FETASONDE UTERINE ACTIVITY MONITORK791039FETASONDE FETAL HEART RATE VARIABILITYK791035FETASONDE FETAL ACTIVITY MONITORK791037FETASONDE LABOR STATUS DISPLAYK791036FETASONDE UTERINE WORK MONITOR

View all 16 devices →

Related Devices (Code: CCE)

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.

K935778VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEMVia Medical Corp.K912145SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIAS & W Medico TeknikK910453TOPS NEEDLE TIP PROBE & PVC TIP PROBEBaxter Healthcare CorpK905397PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEMPuritan Bennett Corp.K896311OPTEX BLOOD GAS MONITORING SYSTEMOptex BiomedicalK890624TISSUE OXYGEN MONITOR SYSTEM, MODEL IIBaxter Healthcare 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.

↑