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)

COMFORT COUGH

K-Number: K113549 · 2013-02-21

ApplicantSeoil Pacific Corp.
Decision Date2013-02-21
Product CodeNHJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

COMFORT COUGH is the device name listed in this FDA 510(k) record. The listed applicant is Seoil Pacific Corp.. It received FDA 510(k) clearance on 2013-02-21 under 510(k) number K113549. The device is classified under product code NHJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMFORT COUGH?

COMFORT COUGH is a medical device that received FDA 510(k) clearance on 2013-02-21. The listed applicant is Seoil Pacific Corp.. The 510(k) number is K113549.

When did COMFORT COUGH receive FDA 510(k) clearance?

COMFORT COUGH received FDA 510(k) clearance on 2013-02-21, under 510(k) number K113549.

Who is the listed applicant for COMFORT COUGH?

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

What is the FDA product code for COMFORT COUGH?

The FDA product code for COMFORT COUGH is NHJ.

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

Related Devices (Code: NHJ)

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.

K260604BiWaze Clear SystemAbmrc, LLCK253001KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)Hunan Ruijiong Biotech Co., Ltd.K242438ClearoBreas Medical ABK231728BiWaze Clear SystemAbmrc, LLCK213564BiWaze Clear SystemAbmrc, LLCK200988Maximus SystemHill-Rom Services Pte, Ltd.

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.

↑