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)

SECOND WIND AIR PURIFIER

K-Number: K980745 · 1999-04-02

ApplicantMonagan Ent., Inc.
Decision Date1999-04-02
Product CodeFRA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SECOND WIND AIR PURIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Monagan Ent., Inc.. It received FDA 510(k) clearance on 1999-04-02 under 510(k) number K980745. The device is classified under product code FRA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SECOND WIND AIR PURIFIER?

SECOND WIND AIR PURIFIER is a medical device that received FDA 510(k) clearance on 1999-04-02. The listed applicant is Monagan Ent., Inc.. The 510(k) number is K980745.

When did SECOND WIND AIR PURIFIER receive FDA 510(k) clearance?

SECOND WIND AIR PURIFIER received FDA 510(k) clearance on 1999-04-02, under 510(k) number K980745.

Who is the listed applicant for SECOND WIND AIR PURIFIER?

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

What is the FDA product code for SECOND WIND AIR PURIFIER?

The FDA product code for SECOND WIND AIR PURIFIER is FRA.

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: FRA)

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.

K252128Zener® (model ZEN-001-B1)Uvx, Inc.K241140ViroZap Indoor Air Purifier, In Duct Model 1008Applied Photonix, LLCK232642AirKEE T900Healkee Medical Pte, Ltd.K232933AirKEE P900Healkee Medical Pte, Ltd.K232645Airgle Room Air PurifierAirgle CorporationK221540Synexis Sphere RxSynexis, LLC

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.

↑