Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification
  • Print
  • Share
  • E-mail
-
New Search Back to Search Results
Device tempo pilot bh: behavioral health
Definition TEMPO Pilot: behavioral health (depression or anxiety)
Physical State TEMPO Pilot: behavioral health (depression or anxiety)
Technical Method Digital Health Device
Target Area TEMPO Pilot: behavioral health (depression or anxiety)
Review Panel Clinical Chemistry
Product CodeSIE
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Not Classified Reason Enforcement Discretion
Submission Type Enforcement Discretion
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
-
-