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)

CARESCAPE MONITOR B450

K-Number: K132533 · 2013-12-04

ApplicantGE Healthcare Finland Oy
Decision Date2013-12-04
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARESCAPE MONITOR B450 is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare Finland Oy. It received FDA 510(k) clearance on 2013-12-04 under 510(k) number K132533. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARESCAPE MONITOR B450?

CARESCAPE MONITOR B450 is a medical device that received FDA 510(k) clearance on 2013-12-04. The listed applicant is GE Healthcare Finland Oy. The 510(k) number is K132533.

When did CARESCAPE MONITOR B450 receive FDA 510(k) clearance?

CARESCAPE MONITOR B450 received FDA 510(k) clearance on 2013-12-04, under 510(k) number K132533.

Who is the listed applicant for CARESCAPE MONITOR B450?

The FDA 510(k) record lists GE Healthcare Finland Oy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARESCAPE MONITOR B450?

The FDA product code for CARESCAPE MONITOR B450 is MHX.

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 GE Healthcare Finland Oy 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.

K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0MK260343Carescape Canvas 1000; Carescape Canvas Smart DisplayK223531CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)K213363CARESCAPE B450, E-musbK213336Carescape B850, E-musbK213181CARESCAPE B650, E-musb

View all 29 devices →

Related Devices (Code: MHX)

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.

K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0MGE Healthcare Finland OyK260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland OyK260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM and AccessoriesMasimo Corporation

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.

↑