HEATMARKER TIME TEMPERATURE INDICATOR
FDA 510(k) clearance K063759 · decided 2007-08-15
Clearance details
- K-number
- K063759
- Device name
- HEATMARKER TIME TEMPERATURE INDICATOR
- Applicant
- Temptime Corporation
- Decision
- Substantially Equivalent
- Date received
- 2006-12-19
- Decision date
- 2007-08-15
- Days to decision
- 239 days
- Clearance type
- Traditional
- Product code
- OCI
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Morris Plains, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.