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FDA 510(k)

REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP

K-Number: K103704 · 2012-03-23

ApplicantZephyr Sleep Technologies, Inc.
Decision Date2012-03-23
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP is the device name listed in this FDA 510(k) record. The listed applicant is Zephyr Sleep Technologies, Inc.. It received FDA 510(k) clearance on 2012-03-23 under 510(k) number K103704. 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 REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP?

REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP is a medical device that received FDA 510(k) clearance on 2012-03-23. The listed applicant is Zephyr Sleep Technologies, Inc.. The 510(k) number is K103704.

When did REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP receive FDA 510(k) clearance?

REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP received FDA 510(k) clearance on 2012-03-23, under 510(k) number K103704.

Who is the listed applicant for REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP?

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

What is the FDA product code for REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP?

The FDA product code for REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP is LRK.

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Other records listing Zephyr Sleep Technologies, 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.

K190051TD Clip

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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