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)

DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400

K-Number: K992638 · 2000-02-24

ApplicantCritikon Company, LLC
Decision Date2000-02-24
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400 is the device name listed in this FDA 510(k) record. The listed applicant is Critikon Company, LLC. It received FDA 510(k) clearance on 2000-02-24 under 510(k) number K992638. 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 DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400?

DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400 is a medical device that received FDA 510(k) clearance on 2000-02-24. The listed applicant is Critikon Company, LLC. The 510(k) number is K992638.

When did DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400 receive FDA 510(k) clearance?

DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400 received FDA 510(k) clearance on 2000-02-24, under 510(k) number K992638.

Who is the listed applicant for DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400?

The FDA 510(k) record lists Critikon Company, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400?

The FDA product code for DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400 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 Critikon Company, LLC 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.

K002248DINAMAP PRO 1000 MONITOR, MODEL 1000K000500DINAMAP ADVANCED NIBP MODULEK982342DINAMAP MPS SELECT PORTABLE MONITORK943709DINAMAP PLUS VITAL SIGNS MONOITORK942700DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340K933404CRITIKON CENTRAL STATIN MONITOR

View all 51 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.

↑