Last synced on 30 September 2022 at 11:05 pm

MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K133064
510(k) Type
Traditional
Applicant
ENVITEC-WISMAR GMBH
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/2/2014
Days to Decision
217 days
Submission Type
Summary

MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K133064
510(k) Type
Traditional
Applicant
ENVITEC-WISMAR GMBH
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/2/2014
Days to Decision
217 days
Submission Type
Summary