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FDA 510(k)

OASYS-ORAL AIRWAY SYSTEM

K-Number: K030440 · 2003-08-26

ApplicantMark Abramson, D.D.S., Inc.
Decision Date2003-08-26
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OASYS-ORAL AIRWAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mark Abramson, D.D.S., Inc.. It received FDA 510(k) clearance on 2003-08-26 under 510(k) number K030440. 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 OASYS-ORAL AIRWAY SYSTEM?

OASYS-ORAL AIRWAY SYSTEM is a medical device that received FDA 510(k) clearance on 2003-08-26. The listed applicant is Mark Abramson, D.D.S., Inc.. The 510(k) number is K030440.

When did OASYS-ORAL AIRWAY SYSTEM receive FDA 510(k) clearance?

OASYS-ORAL AIRWAY SYSTEM received FDA 510(k) clearance on 2003-08-26, under 510(k) number K030440.

Who is the listed applicant for OASYS-ORAL AIRWAY SYSTEM?

The FDA 510(k) record lists Mark Abramson, D.D.S., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OASYS-ORAL AIRWAY SYSTEM?

The FDA product code for OASYS-ORAL AIRWAY SYSTEM is LRK.

Related Clinical Trials

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Other records listing Mark Abramson, D.D.S., 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.

K181571OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor

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

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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