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FDA 510(k)

ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE

K-Number: K973884 · 1998-01-09

ApplicantFrantz Design, Inc.
Decision Date1998-01-09
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE is the device name listed in this FDA 510(k) record. The listed applicant is Frantz Design, Inc.. It received FDA 510(k) clearance on 1998-01-09 under 510(k) number K973884. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE?

ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE is a medical device that received FDA 510(k) clearance on 1998-01-09. The listed applicant is Frantz Design, Inc.. The 510(k) number is K973884.

When did ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE receive FDA 510(k) clearance?

ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE received FDA 510(k) clearance on 1998-01-09, under 510(k) number K973884.

Who is the listed applicant for ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE?

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

What is the FDA product code for ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE?

The FDA product code for ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE is LRK.

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 Frantz Design, 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.

K971794ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE

Related Devices (Code: LRK)

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.

K262104Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)Ram.Shaw Pte., Ltd.K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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