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)

CARDIOVASCULAR MEASUREMENT SYSTEM-CMS

K-Number: K940172 · 1994-09-29

ApplicantMedis Medical Imaging Systems, Inc.
Decision Date1994-09-29
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARDIOVASCULAR MEASUREMENT SYSTEM-CMS is the device name listed in this FDA 510(k) record. The listed applicant is Medis Medical Imaging Systems, Inc.. It received FDA 510(k) clearance on 1994-09-29 under 510(k) number K940172. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOVASCULAR MEASUREMENT SYSTEM-CMS?

CARDIOVASCULAR MEASUREMENT SYSTEM-CMS is a medical device that received FDA 510(k) clearance on 1994-09-29. The listed applicant is Medis Medical Imaging Systems, Inc.. The 510(k) number is K940172.

When did CARDIOVASCULAR MEASUREMENT SYSTEM-CMS receive FDA 510(k) clearance?

CARDIOVASCULAR MEASUREMENT SYSTEM-CMS received FDA 510(k) clearance on 1994-09-29, under 510(k) number K940172.

Who is the listed applicant for CARDIOVASCULAR MEASUREMENT SYSTEM-CMS?

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

What is the FDA product code for CARDIOVASCULAR MEASUREMENT SYSTEM-CMS?

The FDA product code for CARDIOVASCULAR MEASUREMENT SYSTEM-CMS is IZI.

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

Related Devices (Code: IZI)

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.

K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker EndoscopyK253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage CorporationK243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbHK243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986Modus IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH

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.

↑