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FDA 510(k)

ZZOMA POSITIONAL SLEEPER MODEL 001

K-Number: K100160 · 2010-05-11

ApplicantSleep Specialists, LLC
Decision Date2010-05-11
Product CodeMYB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZZOMA POSITIONAL SLEEPER MODEL 001 is the device name listed in this FDA 510(k) record. The listed applicant is Sleep Specialists, LLC. It received FDA 510(k) clearance on 2010-05-11 under 510(k) number K100160. The device is classified under product code MYB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZZOMA POSITIONAL SLEEPER MODEL 001?

ZZOMA POSITIONAL SLEEPER MODEL 001 is a medical device that received FDA 510(k) clearance on 2010-05-11. The listed applicant is Sleep Specialists, LLC. The 510(k) number is K100160.

When did ZZOMA POSITIONAL SLEEPER MODEL 001 receive FDA 510(k) clearance?

ZZOMA POSITIONAL SLEEPER MODEL 001 received FDA 510(k) clearance on 2010-05-11, under 510(k) number K100160.

Who is the listed applicant for ZZOMA POSITIONAL SLEEPER MODEL 001?

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

What is the FDA product code for ZZOMA POSITIONAL SLEEPER MODEL 001?

The FDA product code for ZZOMA POSITIONAL SLEEPER MODEL 001 is MYB.

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Related Devices (Code: MYB)

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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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