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)

VITALERT 3000 MONITORING SYSTEM

K-Number: K913995 · 1992-11-03

ApplicantDraeger Medical, Inc.
Decision Date1992-11-03
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VITALERT 3000 MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical, Inc.. It received FDA 510(k) clearance on 1992-11-03 under 510(k) number K913995. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITALERT 3000 MONITORING SYSTEM?

VITALERT 3000 MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1992-11-03. The listed applicant is Draeger Medical, Inc.. The 510(k) number is K913995.

When did VITALERT 3000 MONITORING SYSTEM receive FDA 510(k) clearance?

VITALERT 3000 MONITORING SYSTEM received FDA 510(k) clearance on 1992-11-03, under 510(k) number K913995.

Who is the listed applicant for VITALERT 3000 MONITORING SYSTEM?

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

What is the FDA product code for VITALERT 3000 MONITORING SYSTEM?

The FDA product code for VITALERT 3000 MONITORING SYSTEM is CCK.

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 Draeger Medical, 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.

K042607PRIMUS USK042419FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEMK042276D-VAPORK042086FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEMK041622MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEMK040847MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR

View all 78 devices →

Related Devices (Code: CCK)

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.

K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden CorporationK261633VisuBreathAffirm Medical Technologies II, LLCK253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLCK250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden CorporationK2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling lineBarbaras Development, Inc.

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.

↑