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FDA 510(k)

MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD)

K-Number: K883416 · 1988-10-12

ApplicantScott All-Sports, Inc.
Decision Date1988-10-12
Product CodeJXL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD) is the device name listed in this FDA 510(k) record. The listed applicant is Scott All-Sports, Inc.. It received FDA 510(k) clearance on 1988-10-12 under 510(k) number K883416. The device is classified under product code JXL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD)?

MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD) is a medical device that received FDA 510(k) clearance on 1988-10-12. The listed applicant is Scott All-Sports, Inc.. The 510(k) number is K883416.

When did MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD) receive FDA 510(k) clearance?

MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD) received FDA 510(k) clearance on 1988-10-12, under 510(k) number K883416.

Who is the listed applicant for MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD)?

The FDA 510(k) record lists Scott All-Sports, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD)?

The FDA product code for MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD) is JXL.

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 Scott All-Sports, Inc. 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.

K901563MOUTHPIECE BREATHING

Related Devices (Code: JXL)

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.

K221469PATI (Protector Against Tongue Injury)Neurovice, LLCK201309ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size MediumMecta CorporationK172978SurgeoBiteSurgovations, LLCK050188EPIGUARDEpisafe Medical Devices, Ltd.K992269VENTIL-A ORAL PROTECTORSomatics, Inc.K960663UNIVERSAL BITE BLOCKB&B Medical Technologies, 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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