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FDA 510(k)

BREATH CONTROL GAME

K-Number: K761116 · 1976-12-02

ApplicantFred Sammons, Inc.
Decision Date1976-12-02
Product CodeILT
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BREATH CONTROL GAME is the device name listed in this FDA 510(k) record. The listed applicant is Fred Sammons, Inc.. It received FDA 510(k) clearance on 1976-12-02 under 510(k) number K761116. The device is classified under product code ILT. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREATH CONTROL GAME?

BREATH CONTROL GAME is a medical device that received FDA 510(k) clearance on 1976-12-02. The listed applicant is Fred Sammons, Inc.. The 510(k) number is K761116.

When did BREATH CONTROL GAME receive FDA 510(k) clearance?

BREATH CONTROL GAME received FDA 510(k) clearance on 1976-12-02, under 510(k) number K761116.

Who is the listed applicant for BREATH CONTROL GAME?

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

What is the FDA product code for BREATH CONTROL GAME?

The FDA product code for BREATH CONTROL GAME is ILT.

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Other records listing Fred Sammons, 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.

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Related Devices (Code: ILT)

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.

K823657CARD HOLDER FOR QUADSFred Sammons, Inc.K823656SOFT CATCHER'S MITTFred Sammons, Inc.K781199HOLDER, CARD, QUAD-QUIPFred Sammons, Inc.K760288VIEWER, RECLINING, BK-4089Fred Sammons, Inc.K760306CARDS, GIANT FACE PLAYING BK-9419Fred Sammons, Inc.K760291HOLDER, PENCIL & CRAYON, WITH STANDFred Sammons, 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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