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FDA 510(k)

AURADORM (NEUROMUSCULAR SLEEP)

K-Number: K101155 · 2011-05-12

ApplicantSleepwright
Decision Date2011-05-12
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AURADORM (NEUROMUSCULAR SLEEP) is the device name listed in this FDA 510(k) record. The listed applicant is Sleepwright. It received FDA 510(k) clearance on 2011-05-12 under 510(k) number K101155. 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 AURADORM (NEUROMUSCULAR SLEEP)?

AURADORM (NEUROMUSCULAR SLEEP) is a medical device that received FDA 510(k) clearance on 2011-05-12. The listed applicant is Sleepwright. The 510(k) number is K101155.

When did AURADORM (NEUROMUSCULAR SLEEP) receive FDA 510(k) clearance?

AURADORM (NEUROMUSCULAR SLEEP) received FDA 510(k) clearance on 2011-05-12, under 510(k) number K101155.

Who is the listed applicant for AURADORM (NEUROMUSCULAR SLEEP)?

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

What is the FDA product code for AURADORM (NEUROMUSCULAR SLEEP)?

The FDA product code for AURADORM (NEUROMUSCULAR SLEEP) 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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