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)

SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX

K-Number: K062098 · 2007-02-05

ApplicantDatascope Corp.
Decision Date2007-02-05
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 2007-02-05 under 510(k) number K062098. 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 SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX?

SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX is a medical device that received FDA 510(k) clearance on 2007-02-05. The listed applicant is Datascope Corp.. The 510(k) number is K062098.

When did SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX receive FDA 510(k) clearance?

SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX received FDA 510(k) clearance on 2007-02-05, under 510(k) number K062098.

Who is the listed applicant for SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX?

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

What is the FDA product code for SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX?

The FDA product code for SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX 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 Datascope 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.

K190884TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery ToolK181122CARDIOSAVE Intra-Aortic Balloon PumpK172305CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpK163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage CaseK133074MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIESK071805NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX

View all 135 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.

↑