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)

MINI NICHOLES

K-Number: K812098 · 1981-08-18

ApplicantHealthcare Ind.
Decision Date1981-08-18
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MINI NICHOLES is the device name listed in this FDA 510(k) record. The listed applicant is Healthcare Ind.. It received FDA 510(k) clearance on 1981-08-18 under 510(k) number K812098. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINI NICHOLES?

MINI NICHOLES is a medical device that received FDA 510(k) clearance on 1981-08-18. The listed applicant is Healthcare Ind.. The 510(k) number is K812098.

When did MINI NICHOLES receive FDA 510(k) clearance?

MINI NICHOLES received FDA 510(k) clearance on 1981-08-18, under 510(k) number K812098.

Who is the listed applicant for MINI NICHOLES?

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

What is the FDA product code for MINI NICHOLES?

The FDA product code for MINI NICHOLES is CAH.

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 Healthcare Ind. 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.

K812075NICHOLE'S 99

Related Devices (Code: CAH)

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.

K252643Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledTeleflex Medical Sdn. Bhd.K251583Ambu® Virobac II® Exhalation FilterAmbu A/SK241339Besmed Bacterial Filter and HMEFBesmed Health Business CorpK222917Breathing circuit bacterial/viral filterShaoxing Haitech Medical Products Co., Ltd.K230483Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)Passy-Muir, Inc.K223258TNI Clear-Guard™ 3 angled breathing filter (1545020)Intersurgical , 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.

↑