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FDA 510(k)

Diamond Digital Sleep Orthotic (DDSO)

K-Number: K202499 · 2020-09-03

ApplicantDiamond Orthotic Laboratory
Decision Date2020-09-03
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Diamond Digital Sleep Orthotic (DDSO) is the device name listed in this FDA 510(k) record. The listed applicant is Diamond Orthotic Laboratory. It received FDA 510(k) clearance on 2020-09-03 under 510(k) number K202499. 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 Diamond Digital Sleep Orthotic (DDSO)?

Diamond Digital Sleep Orthotic (DDSO) is a medical device that received FDA 510(k) clearance on 2020-09-03. The listed applicant is Diamond Orthotic Laboratory. The 510(k) number is K202499.

When did Diamond Digital Sleep Orthotic (DDSO) receive FDA 510(k) clearance?

Diamond Digital Sleep Orthotic (DDSO) received FDA 510(k) clearance on 2020-09-03, under 510(k) number K202499.

Who is the listed applicant for Diamond Digital Sleep Orthotic (DDSO)?

The FDA 510(k) record lists Diamond Orthotic Laboratory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diamond Digital Sleep Orthotic (DDSO)?

The FDA product code for Diamond Digital Sleep Orthotic (DDSO) is LRK.

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.

K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLCK253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte. , Ltd.

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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