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)

MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214

K-Number: K090785 · 2009-12-15

ApplicantInvivo Corp.
Decision Date2009-12-15
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214 is the device name listed in this FDA 510(k) record. The listed applicant is Invivo Corp.. It received FDA 510(k) clearance on 2009-12-15 under 510(k) number K090785. 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 MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214?

MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214 is a medical device that received FDA 510(k) clearance on 2009-12-15. The listed applicant is Invivo Corp.. The 510(k) number is K090785.

When did MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214 receive FDA 510(k) clearance?

MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214 received FDA 510(k) clearance on 2009-12-15, under 510(k) number K090785.

Who is the listed applicant for MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214?

The FDA 510(k) record lists Invivo Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214?

The FDA product code for MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214 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 Invivo Corp. 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.

K052704MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICEK052497NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-AK051512CAC-127-8 CARDOAC ARRAY COIL

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.

↑