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FDA 510(k)

RESPIRONICS CUSTOM I ORAL APPLIANCE

K-Number: K033822 · 2004-02-06

ApplicantRespironics, Inc.
Decision Date2004-02-06
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RESPIRONICS CUSTOM I ORAL APPLIANCE is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2004-02-06 under 510(k) number K033822. 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 RESPIRONICS CUSTOM I ORAL APPLIANCE?

RESPIRONICS CUSTOM I ORAL APPLIANCE is a medical device that received FDA 510(k) clearance on 2004-02-06. The listed applicant is Respironics, Inc.. The 510(k) number is K033822.

When did RESPIRONICS CUSTOM I ORAL APPLIANCE receive FDA 510(k) clearance?

RESPIRONICS CUSTOM I ORAL APPLIANCE received FDA 510(k) clearance on 2004-02-06, under 510(k) number K033822.

Who is the listed applicant for RESPIRONICS CUSTOM I ORAL APPLIANCE?

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

What is the FDA product code for RESPIRONICS CUSTOM I ORAL APPLIANCE?

The FDA product code for RESPIRONICS CUSTOM I ORAL APPLIANCE is LRK.

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Related Devices (Code: LRK)

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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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