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ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K103584
510(k) Type
Traditional
Applicant
SHENZHEN ENVISEN INDUSTRY CO. LIMITED
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/10/2011
Days to Decision
185 days
Submission Type
Summary

ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K103584
510(k) Type
Traditional
Applicant
SHENZHEN ENVISEN INDUSTRY CO. LIMITED
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/10/2011
Days to Decision
185 days
Submission Type
Summary