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)

VITAL SYNC SYSTEM

K-Number: K123002 · 2013-02-27

ApplicantCovidien, Formerly Nellcor Puritan Bennett, Inc.
Decision Date2013-02-27
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VITAL SYNC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, Formerly Nellcor Puritan Bennett, Inc.. It received FDA 510(k) clearance on 2013-02-27 under 510(k) number K123002. 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 VITAL SYNC SYSTEM?

VITAL SYNC SYSTEM is a medical device that received FDA 510(k) clearance on 2013-02-27. The listed applicant is Covidien, Formerly Nellcor Puritan Bennett, Inc.. The 510(k) number is K123002.

When did VITAL SYNC SYSTEM receive FDA 510(k) clearance?

VITAL SYNC SYSTEM received FDA 510(k) clearance on 2013-02-27, under 510(k) number K123002.

Who is the listed applicant for VITAL SYNC SYSTEM?

The FDA 510(k) record lists Covidien, Formerly Nellcor Puritan Bennett, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITAL SYNC SYSTEM?

The FDA product code for VITAL SYNC SYSTEM 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 Covidien, Formerly Nellcor Puritan Bennett, 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.

K123581NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIENK092847840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTIONK083693PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840K082966PB 540 VENTILATOR

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.

↑