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)

HALOLITE AAD SYSTEM

K-Number: K981772 · 1998-11-03

ApplicantMedic-Aid , Ltd.
Decision Date1998-11-03
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HALOLITE AAD SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medic-Aid , Ltd.. It received FDA 510(k) clearance on 1998-11-03 under 510(k) number K981772. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HALOLITE AAD SYSTEM?

HALOLITE AAD SYSTEM is a medical device that received FDA 510(k) clearance on 1998-11-03. The listed applicant is Medic-Aid , Ltd.. The 510(k) number is K981772.

When did HALOLITE AAD SYSTEM receive FDA 510(k) clearance?

HALOLITE AAD SYSTEM received FDA 510(k) clearance on 1998-11-03, under 510(k) number K981772.

Who is the listed applicant for HALOLITE AAD SYSTEM?

The FDA 510(k) record lists Medic-Aid , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HALOLITE AAD SYSTEM?

The FDA product code for HALOLITE AAD SYSTEM is CAF.

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 Medic-Aid , Ltd. 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.

K991685HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSORK971933PORT-NEBK934749FREEWAY LITE NEBULIZER COMPRESSORK940888SYSTEM 22 PAEDIATRIC MASKK940887SYSTEM 22 ADULT MASKK933535VENTSTREAM DRUG NEBULIZER

View all 9 devices →

Related Devices (Code: CAF)

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.

K254171Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)Shenzhen Mericonn Technology Co., Ltd.K260270FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)FindAir Sp. z o.o.K251572eRapid with eTrack SystemPari Respiratory Equipment, Inc.K251659Mesh Nebulizer (H6)Qingdao Future Medical Technology Co., Ltd.K244035Portable mesh nebulizer (JM821)Shenzhen Jermei Medical Device Technology Co., Ltd.K243468Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)Joytech Healthcare Co. , 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.

↑