Atlas FDA

CELSIUS CONTROL SYSTEM

FDA 510(k) clearance K022366 · decided 2003-01-27

Clearance details

K-number
K022366
Device name
CELSIUS CONTROL SYSTEM
Applicant
Innercool Therapies
Decision
Substantially Equivalent
Date received
2002-07-22
Decision date
2003-01-27
Days to decision
189 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.