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FDA 510(k)

IMPROVED MOUTHPIECE

K-Number: K840459 · 1984-02-17

ApplicantKinetix
Decision Date1984-02-17
Product CodeBYP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

IMPROVED MOUTHPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Kinetix. It received FDA 510(k) clearance on 1984-02-17 under 510(k) number K840459. The device is classified under product code BYP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPROVED MOUTHPIECE?

IMPROVED MOUTHPIECE is a medical device that received FDA 510(k) clearance on 1984-02-17. The listed applicant is Kinetix. The 510(k) number is K840459.

When did IMPROVED MOUTHPIECE receive FDA 510(k) clearance?

IMPROVED MOUTHPIECE received FDA 510(k) clearance on 1984-02-17, under 510(k) number K840459.

Who is the listed applicant for IMPROVED MOUTHPIECE?

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

What is the FDA product code for IMPROVED MOUTHPIECE?

The FDA product code for IMPROVED MOUTHPIECE is BYP.

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 Kinetix 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.

K832401RESPIROMETERK833420KINETIX MOUTHPIECEK833012INSPIROMETER

Related Devices (Code: BYP)

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.

K955657NORTH STATE PLASTICS RESPIRATORY MOUTHPIECENorth State Plastics, Inc.K944512TRUZONE PFM DISPOSABLE MOUTHPIECEMonaghan Medical Corp.K893791BREATHING MOUTHPIECEDiemolding Corp.K872037AEROCHAMBERMonaghan Medical Corp.K865093SAFE-T-SHIELD MOUTHPIECEMedi Nuclear Corp., Inc.K863049INHALATION AIDBoehringer Ingelheim Pharmaceuticals, 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.

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