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)

CM5000R REMOTE INDICATOR

K-Number: K931394 · 1993-07-01

ApplicantCanadian Monaghan , Ltd.
Decision Date1993-07-01
Product CodeCAP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CM5000R REMOTE INDICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Canadian Monaghan , Ltd.. It received FDA 510(k) clearance on 1993-07-01 under 510(k) number K931394. The device is classified under product code CAP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CM5000R REMOTE INDICATOR?

CM5000R REMOTE INDICATOR is a medical device that received FDA 510(k) clearance on 1993-07-01. The listed applicant is Canadian Monaghan , Ltd.. The 510(k) number is K931394.

When did CM5000R REMOTE INDICATOR receive FDA 510(k) clearance?

CM5000R REMOTE INDICATOR received FDA 510(k) clearance on 1993-07-01, under 510(k) number K931394.

Who is the listed applicant for CM5000R REMOTE INDICATOR?

The FDA 510(k) record lists Canadian Monaghan , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CM5000R REMOTE INDICATOR?

The FDA product code for CM5000R REMOTE INDICATOR is CAP.

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 Canadian Monaghan , Ltd. 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.

K931287CM7000 REMOTE INDICATORK925673AIRWAY PRESSURE MONITOR CM 5000 NGANK873953CM 5000R REMOTE AIRWAY PRESSUREK871083CM 5000 MONITOR AIRWAY PRESSURE

Related Devices (Code: CAP)

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.

K201666SINGLE USE MANOMETERFlexicare Medical Limited.K182292VORTRAN APM-PlusVortran Medical Technology 1, Inc.K180510NS 120P-TRS Airway Pressure GaugeInstrumentation Industries, Inc.K172284NAPA LP-15 Airway Pressure MonitorDrw Medical, LLCK153733VORTRAN ManometerVortran Medical Technology 1, Inc.K122627GIO DIGITAL PRESSURE GUAGESGalemed 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.

↑