SILENT NIGHT II— 510(k) K981034

Substantially Equivalent

Sleep Solutions, Inc.

FDA 510(k) clearance K981034 for SILENT NIGHT II, Substantially Equivalent on 1998-10-30. Applicant: Sleep Solutions, Inc.. Device class: 2.

Clearance details

Applicant
Sleep Solutions, Inc.
Product code
Code MNR
Device class
Class 2
Regulation
21 CFR 868.2375
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Houston, TX, US
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