Atlas FDA

CELSIUS CONTROL SYSTEM

FDA 510(k) clearance K033623 · decided 2004-05-21

Clearance details

K-number
K033623
Device name
CELSIUS CONTROL SYSTEM
Applicant
Innercool Therapies, Inc.
Decision
Substantially Equivalent
Date received
2003-11-18
Decision date
2004-05-21
Days to decision
185 days
Clearance type
Traditional
Product code
NCX
Device class
2
Regulation number
870.5900
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
San Diego,, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.