Last synced on 30 September 2022 at 11:05 pm

B-SMART, MODEL B-01

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K031128
510(k) Type
Traditional
Applicant
MACOSTA MEDICAL USA, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/15/2004
Days to Decision
281 days
Submission Type
Statement

B-SMART, MODEL B-01

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K031128
510(k) Type
Traditional
Applicant
MACOSTA MEDICAL USA, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/15/2004
Days to Decision
281 days
Submission Type
Statement