Atlas FDA

SOLCART B

FDA 510(k) clearance K072760 · decided 2008-01-29

Clearance details

K-number
K072760
Device name
SOLCART B
Applicant
B. Braun Medizintechnologie GmbH
Decision
Substantially Equivalent
Date received
2007-09-28
Decision date
2008-01-29
Days to decision
123 days
Clearance type
Traditional
Product code
KPO
Device class
2
Regulation number
876.5820
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Allentown, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.