Atlas FDA

TEMPEDY

FDA 510(k) clearance K152946 · decided 2016-09-15

Clearance details

K-number
K152946
Device name
TEMPEDY
Applicant
Seiratherm GmbH
Decision
Substantially Equivalent
Date received
2015-10-06
Decision date
2016-09-15
Days to decision
345 days
Clearance type
Traditional
Product code
NCX
Device class
2
Regulation number
870.5900
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
91074 Herzogenaurach, DE
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.