510(k) clearances

Sentec Digital Monitoring System (SDMS) tCOM+

Sentec AG · Anesthesiology

K232516Substantially EquivalentTraditionalLKD
Open FDA's page for this record
Third party flag
N
City
Therwil
Advisory committee description
Anesthesiology
Address 1
Ringstrasse 39
Statement or summary
Summary
Product code
LKD
Zip code
4106
Applicant
Sentec AG
Decision date
2024-05-17
Decision code
SESE
Country code
CH
Device name
Sentec Digital Monitoring System (SDMS) tCOM+
Advisory committee
AN
Contact
Caroline Moller
K number
K232516
Date received
2023-08-18
Review advisory committee
AN
Postal code
4106
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Monitor, Carbon-Dioxide, Cutaneous
Medical specialty description
Anesthesiology
Regulation number
868.2480
Device class
2
Registration number
3013513377, 3003263092, 3009077524, 8030885, 3000126629, 3012866928, 3013596024, 3004149774, 3013500228, 9614470, 3016701404, 3007490412, 3012528160, 3002807968, 2020676, 3016618143, 3012409105, 9610816
FEI number
3013513377, 3003244961, 3003263092, 3009077524, 3002663379, 3000126629, 3012866928, 3002807167, 3013596024, 3004149774, 3013500228, 3016701404, 3007490412, 3012528160, 3002807968, 2020676, 3016618143, 3012409105
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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.