510(k) clearances

Hushd Pro Avera

Good Sleep CO Pte , Ltd. · Dental

K232025Substantially EquivalentTraditionalLRK
Open FDA's page for this record
Third party flag
N
City
Singapore
Advisory committee description
Dental
Address 1
226 Ocean Dr.
Statement or summary
Summary
Product code
LRK
Zip code
098617
Applicant
Good Sleep CO Pte , Ltd.
Decision date
2024-05-09
Decision code
SESE
Country code
SG
Device name
Hushd Pro Avera
Advisory committee
DE
Contact
Joel Simoson
K number
K232025
Date received
2023-07-07
Review advisory committee
DE
Postal code
098617
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Device, Anti-Snoring
Medical specialty description
Dental
Regulation number
872.5570
Device class
2
Registration number
3012716038, 3018094310, 3003460151, 1825660, 3008313791, 3010852338, 8010019, 3027346720, 1937100, 3005730680, 3000171384, 3009549393, 3038209294, 3002911411, 3039443708, 3003928050, 3031978086, 3017567754, 3015674959, 3009779268, 3008102163, 3011170140, 2031093, 3007233968, 3012539501, 3012728846, 3008763803, 3009401301, 3025306497, 3003496134, 3000126629, 3003283852, 3009440973, 3013652641, 3002706372, 3012359952, 3006650414, 3004964738, 3001295407, 3017520337 +68 more
FEI number
3012716038, 3018094310, 1825660, 3008313791, 3010852338, 3027346720, 1937100, 3005730680, 3000171384, 3009549393, 3038209294, 3002911411, 3001003585, 3039443708, 3003928050, 3031978086, 3017567754, 3003767844, 3015674959, 3009779268, 3008102163, 3011170140, 3007233968, 3012539501, 3012728846, 3008763803, 3001236549, 3009401301, 3025306497, 3003496134, 3000126629, 3003283852, 3003322666, 3009440973, 3013652641, 3002706372, 3004588608, 3012359952, 3006650414, 3004964738 +68 more
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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.