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)

MODIFIED AEROCHAMBER WITH MASK

K-Number: K900576 · 1991-05-13

ApplicantMonaghan Medical Corp.
Decision Date1991-05-13
Product CodeCCQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFIED AEROCHAMBER WITH MASK is the device name listed in this FDA 510(k) record. The listed applicant is Monaghan Medical Corp.. It received FDA 510(k) clearance on 1991-05-13 under 510(k) number K900576. The device is classified under product code CCQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED AEROCHAMBER WITH MASK?

MODIFIED AEROCHAMBER WITH MASK is a medical device that received FDA 510(k) clearance on 1991-05-13. The listed applicant is Monaghan Medical Corp.. The 510(k) number is K900576.

When did MODIFIED AEROCHAMBER WITH MASK receive FDA 510(k) clearance?

MODIFIED AEROCHAMBER WITH MASK received FDA 510(k) clearance on 1991-05-13, under 510(k) number K900576.

Who is the listed applicant for MODIFIED AEROCHAMBER WITH MASK?

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

What is the FDA product code for MODIFIED AEROCHAMBER WITH MASK?

The FDA product code for MODIFIED AEROCHAMBER WITH MASK is CCQ.

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 Monaghan Medical 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.

K123945STRIVE DUAL ZONE PEAK FLOW METERK031514MODIFICATION TO TRUPEAK PEAK FLOW METERK023097TRUEZONE PEAK FLOW METERK012939AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBERK991212MODIFICATION TO TRUZONE PEAK FLOW METERK964130AEROGEAR ASTHMA ACTION KIT

View all 33 devices →

Related Devices (Code: CCQ)

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.

K972397EZ SPRAYIntertex Research, Inc.K964956E-Z SPACER MASK (SMALL)Airpharma, LLCK961894MDI TUTORMdi Tutor, Inc.K961455MEDSHIELD/AEROCHAMBERDiemolding Corp.K960593SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100Aradigm Corp.K922033SALINE SOLUTION- STERILETrinity Laboratories, 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.

↑