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)

MODIFICATION TO MODEL 750 SERIES MONITOR

K-Number: K063087 · 2006-12-11

ApplicantCas Medical Systems, Inc.
Decision Date2006-12-11
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO MODEL 750 SERIES MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Cas Medical Systems, Inc.. It received FDA 510(k) clearance on 2006-12-11 under 510(k) number K063087. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO MODEL 750 SERIES MONITOR?

MODIFICATION TO MODEL 750 SERIES MONITOR is a medical device that received FDA 510(k) clearance on 2006-12-11. The listed applicant is Cas Medical Systems, Inc.. The 510(k) number is K063087.

When did MODIFICATION TO MODEL 750 SERIES MONITOR receive FDA 510(k) clearance?

MODIFICATION TO MODEL 750 SERIES MONITOR received FDA 510(k) clearance on 2006-12-11, under 510(k) number K063087.

Who is the listed applicant for MODIFICATION TO MODEL 750 SERIES MONITOR?

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

What is the FDA product code for MODIFICATION TO MODEL 750 SERIES MONITOR?

The FDA product code for MODIFICATION TO MODEL 750 SERIES MONITOR is MWI.

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 Cas Medical Systems, 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.

K190270FORE-SIGHT ELITE Tissue Oximeter ModuleK180003FORE-SIGHT ELITE Module Tissue OximeterK130411740 SELECTK123700FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETERK112820FORE-SIGHT ABSOLUTE TISSUE OXIMETERK094030FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030

View all 28 devices →

Related Devices (Code: MWI)

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.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo CorporationK253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationK253436c-med0 alphaCosinuss GmbHK250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

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.

↑