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MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K101031
510(k) Type
Traditional
Applicant
MASIMO CORPORATION
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/18/2010
Days to Decision
219 days
Submission Type
Summary

MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K101031
510(k) Type
Traditional
Applicant
MASIMO CORPORATION
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/18/2010
Days to Decision
219 days
Submission Type
Summary