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ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K082655
510(k) Type
Traditional
Applicant
ENVITEC-WISMAR GMBH
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/25/2008
Days to Decision
74 days
Submission Type
Summary

ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K082655
510(k) Type
Traditional
Applicant
ENVITEC-WISMAR GMBH
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/25/2008
Days to Decision
74 days
Submission Type
Summary