SONA PILLOW— 510(k) K040161

Substantially Equivalent

Sleep Devices, Inc.

FDA 510(k) clearance K040161 for SONA PILLOW, Substantially Equivalent on 2004-04-30. Applicant: Sleep Devices, Inc.. Device class: 2.

Clearance details

Applicant: Sleep Devices, Inc.
Product code: Code MYB
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2004-01-23
Decision date: 2004-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kissimmee, FL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.