510(k) clearances

eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)

Signifier Medical Technologies, Ltd. · Dental

K240328Substantially EquivalentSpecialQNO
Open FDA's page for this record
Third party flag
N
City
London
Advisory committee description
Dental
Address 1
5-17 Hammersmith Grove
Statement or summary
Summary
Product code
QNO
Zip code
W6 0LG
Applicant
Signifier Medical Technologies, Ltd.
Decision date
2024-05-16
Decision code
SESE
Country code
GB
Device name
eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)
Advisory committee
DE
Contact
Yasser Zayni
K number
K240328
Date received
2024-02-05
Review advisory committee
DE
Postal code
W6 0LG
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea
Medical specialty description
Dental
Regulation number
872.5575
Device class
2
Registration number
3017430550, 3033509895, 3017737771, 3013445086, 3018192374
FEI number
3017430550, 3033509895, 3017737771, 3013445086, 3018192374
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.