Last synced on 13 May 2022 at 11:05 pm

SPIROTEL, MODEL 29-1020

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K031643
510(k) Type
Traditional
Applicant
SDI DIAGNOSTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/9/2003
Days to Decision
196 days
Submission Type
Statement

SPIROTEL, MODEL 29-1020

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K031643
510(k) Type
Traditional
Applicant
SDI DIAGNOSTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/9/2003
Days to Decision
196 days
Submission Type
Statement