510(k) K063759
K063759 is an FDA 510(k) premarket notification submitted by Temptime Corporation for the device "HEATMARKER TIME TEMPERATURE INDICATOR". The FDA issued a decision of Substantially Equivalent on August 15, 2007. The device falls under product code OCI (Indicator, Physical/Chemical, Storage Temperature), a Class II device regulated under 21 CFR 880.2800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 15, 2007
- Date Received
- December 19, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Indicator, Physical/Chemical, Storage Temperature
- Device Class
- Class II
- Regulation Number
- 880.2800
- Review Panel
- HO
- Submission Type
The time-temperature indicator provides a visual signal that a selected time-temperature profile has been exceeded. When affixed to a device, a time temperature indicator is indicated, via a permanent color change, for the purpose of distinguishing between medical products that have exceeded a selected time-temperature profile of interest to the user from products that have not exceeded that profile.