Serena Sleep

FDA Device Registration & Listing · Hudson, WI, US · Registration 3018783197

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3018783197
FEI Number
3018783197
Entity Name
Serena Sleep
City/State/Country
Hudson, WI, US
Establishment Address
592 Outpost Cir Ste H, Hudson, WI 54016, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Serena Sleep (Owner Number: 10081481)
Owner / Operator Contact Address
592 Outpost Circle Suite H, Hudson, WI 54016, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K230495
PMA Number
N/A

All Registered Proprietary Names

Serena Sleep Ace Serena Sleep Elevate Serena Sleep Night Guard

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LRK Device, Anti-Snoring Dental Class 2 872.5570 2021-04-19
MQC Mouthguard, Prescription Unknown Class U N/A 2023-12-29
OCO Mouthguard, Migraine/Tension Headache Unknown Class U N/A 2023-12-29

Official Correspondent

Sarah Moss

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Serena Sleep
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K122391 Medtronic Xomed, Inc. MEDTRONIC XOMED, INC. 2013-01-10

Similar Registrations

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3017092365 APNOMED, INC. Bellevue, WA, US
3039643908 EMA-SLEEP INC Bastrop, TX, US
3007108578 TRUE FUNCTION LABORATORY INC La Mesa, CA, US
3006786034 Innovative Health Technologies (NZ) Limited Dunedin Otago, NZ
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018783197. Last updated year: 2026. Please use registration number 3018783197 when referencing this establishment in official correspondence.
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