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510(k) K180608

Lunoa System by Nightbalance BV — Product Code MYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2018
Date Received
March 7, 2018
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

  • K140190 — NIGHT SHIFT (May 29, 2014)
  • K100160 — ZZOMA POSITIONAL SLEEPER MODEL 001 (May 11, 2010)
  • K040161 — SONA PILLOW (April 30, 2004)
  • K023010 — SNIFF POSITION PILLOWS/POPITZ PILLOWS (October 1, 2002)
  • K990871 — PILLOWPOSITIVE CERVICAL PILLOW (June 10, 1999)