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)

INSPIRON DOUBLE SWIVEL TRACH ADAPTER

K-Number: K860838 · 1986-04-09

ApplicantInspiron Corp.
Decision Date1986-04-09
Product CodeBZA
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INSPIRON DOUBLE SWIVEL TRACH ADAPTER is the device name listed in this FDA 510(k) record. The listed applicant is Inspiron Corp.. It received FDA 510(k) clearance on 1986-04-09 under 510(k) number K860838. The device is classified under product code BZA. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSPIRON DOUBLE SWIVEL TRACH ADAPTER?

INSPIRON DOUBLE SWIVEL TRACH ADAPTER is a medical device that received FDA 510(k) clearance on 1986-04-09. The listed applicant is Inspiron Corp.. The 510(k) number is K860838.

When did INSPIRON DOUBLE SWIVEL TRACH ADAPTER receive FDA 510(k) clearance?

INSPIRON DOUBLE SWIVEL TRACH ADAPTER received FDA 510(k) clearance on 1986-04-09, under 510(k) number K860838.

Who is the listed applicant for INSPIRON DOUBLE SWIVEL TRACH ADAPTER?

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

What is the FDA product code for INSPIRON DOUBLE SWIVEL TRACH ADAPTER?

The FDA product code for INSPIRON DOUBLE SWIVEL TRACH ADAPTER is BZA.

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 Inspiron 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.

K850346OXYGEN CONCENTRATORK843932VAPOR-PHASE HUMIDIFIER SYS-ADVANCEDK840935MANUAL RESUSCITATION SYSTEMK841158NEBULO 28 NEBULIZER KITK840418INSPIRATORY/EXPIRATORY MUSCLE EXERCISK834290INSPIRON LIQUID OXYGEN SYSTEM

View all 20 devices →

Related Devices (Code: BZA)

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.

K083702TRACH-ASSISTMergenet MedicalK954383SURELOC CIRCUIT CONNECTORPolamedco, Inc.K954197DISPOSABLE FLEX TUBEEngstrom MedicalK953786UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONSUnicor, Inc.K952824NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTORIntertex Medical, Inc.K951345DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLINGCatheter Research, Inc.

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.

↑