Last synced on 6 June 2025 at 11:06 pm

ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K101092
510(k) Type
Traditional
Applicant
MEDIVANCE, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/16/2010
Days to Decision
87 days
Submission Type
Summary

ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K101092
510(k) Type
Traditional
Applicant
MEDIVANCE, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/16/2010
Days to Decision
87 days
Submission Type
Summary