510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MYBClass II

Pillow, Cervical (For Mild Sleep Apnea)

21 CFR 872.5570 / Dental
FDA source (opens on fda.gov)

MYB is the FDA product code for Pillow, Cervical (For Mild Sleep Apnea), a class II device type, regulated under 21 CFR 872.5570. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MYB
Device name
Pillow, Cervical (For Mild Sleep Apnea)
Regulation
21 CFR 872.5570
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
6
Ingested recalls
0

Clearances, product code MYB

By decision year
6 clearances under product code MYB with a decision year between 1999 and 2018, 1999 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MYB by decision year
YearClearances
19991
20021
20041
20101
20141
20181

Applicants with the most clearances

Product code MYB
Applicants holding the most 510(k) clearances under product code MYB
ApplicantClearances
Advanced Brain Monitoring, Inc.1
Aeolus International Corporation1
Lifesleep Systems, Inc.1
Nightbalance BV1
Sleep Devices, Inc.1
Sleep Specialists, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code