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FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K041644
510(k) Type
Traditional
Applicant
ELEKON INDUSTRIES U.S.A., INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/29/2004
Days to Decision
42 days
Submission Type
Summary

FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K041644
510(k) Type
Traditional
Applicant
ELEKON INDUSTRIES U.S.A., INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/29/2004
Days to Decision
42 days
Submission Type
Summary