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510(k) K100160

ZZOMA POSITIONAL SLEEPER MODEL 001 by Sleep Specialists, LLC — Product Code MYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2010
Date Received
January 20, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pillow, Cervical (For Mild Sleep Apnea)
Device Class
Class II
Regulation Number
872.5570
Review Panel
EN
Submission Type

Other clearances for product code MYB

  • K180608 — Lunoa System (June 5, 2018)
  • K140190 — NIGHT SHIFT (May 29, 2014)
  • K040161 — SONA PILLOW (April 30, 2004)
  • K023010 — SNIFF POSITION PILLOWS/POPITZ PILLOWS (October 1, 2002)
  • K990871 — PILLOWPOSITIVE CERVICAL PILLOW (June 10, 1999)