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)

EMERGENCY TRACHEOSTOMY KIT

K-Number: K823872 · 1983-01-21

ApplicantOmnicon Medical Corp.
Decision Date1983-01-21
Product CodeEWC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EMERGENCY TRACHEOSTOMY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Omnicon Medical Corp.. It received FDA 510(k) clearance on 1983-01-21 under 510(k) number K823872. The device is classified under product code EWC. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMERGENCY TRACHEOSTOMY KIT?

EMERGENCY TRACHEOSTOMY KIT is a medical device that received FDA 510(k) clearance on 1983-01-21. The listed applicant is Omnicon Medical Corp.. The 510(k) number is K823872.

When did EMERGENCY TRACHEOSTOMY KIT receive FDA 510(k) clearance?

EMERGENCY TRACHEOSTOMY KIT received FDA 510(k) clearance on 1983-01-21, under 510(k) number K823872.

Who is the listed applicant for EMERGENCY TRACHEOSTOMY KIT?

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

What is the FDA product code for EMERGENCY TRACHEOSTOMY KIT?

The FDA product code for EMERGENCY TRACHEOSTOMY KIT is EWC.

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 Omnicon Medical 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.

K820576MAINFLOW BACTERIA FILTERK820577ANESTHESIA BACTERIA FILTERK801804ANESTHESIA BACTERIA FILTERK801803MAINFLOW BACTERIA FILTERK772060PROTECT IV GARDK770136DISPOSABLE BACTERIA FILTER

View all 10 devices →

Related Devices (Code: EWC)

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.

K822269NAGASHIMA SN SOUND-PROOF CHAMBER-HEARINGKelleher Corp.

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.

↑