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FDA 510(k)

E-Z SPACER MASK (SMALL)

K-Number: K964956 · 1997-04-23

ApplicantAirpharma, LLC
Decision Date1997-04-23
Product CodeCCQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

E-Z SPACER MASK (SMALL) is the device name listed in this FDA 510(k) record. The listed applicant is Airpharma, LLC. It received FDA 510(k) clearance on 1997-04-23 under 510(k) number K964956. 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 E-Z SPACER MASK (SMALL)?

E-Z SPACER MASK (SMALL) is a medical device that received FDA 510(k) clearance on 1997-04-23. The listed applicant is Airpharma, LLC. The 510(k) number is K964956.

When did E-Z SPACER MASK (SMALL) receive FDA 510(k) clearance?

E-Z SPACER MASK (SMALL) received FDA 510(k) clearance on 1997-04-23, under 510(k) number K964956.

Who is the listed applicant for E-Z SPACER MASK (SMALL)?

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

What is the FDA product code for E-Z SPACER MASK (SMALL)?

The FDA product code for E-Z SPACER MASK (SMALL) 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 Airpharma, LLC 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.

K933090EZ-SPACER

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.K961894MDI 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.K900576MODIFIED AEROCHAMBER WITH MASKMonaghan Medical Corp.

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.

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