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FDA 510(k), K100160, ZZOMA POSITIONAL SLEEPER MODEL 001
FDA 510(k), K100160, ZZOMA POSITIONAL SLEEPER MODEL 001
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510(K) Number: K100160
Device Name: ZZOMA POSITIONAL SLEEPER MODEL 001
Manufacturer: HOWARD MANN
Device Classification Name: Pillow, Cervical (For Mild Sleep Apnea)
Regulation Number: MYB
Classification Product Code: 01/20/2010
Date Received: 05/11/2010
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
Device Name: ZZOMA POSITIONAL SLEEPER MODEL 001
Manufacturer: HOWARD MANN
Device Classification Name: Pillow, Cervical (For Mild Sleep Apnea)
Regulation Number: MYB
Classification Product Code: 01/20/2010
Date Received: 05/11/2010
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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