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FDA 510(k)

MOUTHPIECE BREATHING

K-Number: K901563 · 1990-06-28

ApplicantScott All-Sports, Inc.
Decision Date1990-06-28
Product CodeJXL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MOUTHPIECE BREATHING 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 1990-06-28 under 510(k) number K901563. 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?

MOUTHPIECE BREATHING is a medical device that received FDA 510(k) clearance on 1990-06-28. The listed applicant is Scott All-Sports, Inc.. The 510(k) number is K901563.

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

MOUTHPIECE BREATHING received FDA 510(k) clearance on 1990-06-28, under 510(k) number K901563.

Who is the listed applicant for MOUTHPIECE BREATHING?

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?

The FDA product code for MOUTHPIECE BREATHING 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.

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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.

K883416MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD)

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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