The following data is part of a premarket notification filed by Temptime Corporation with the FDA for Heatmarker Time Temperature Indicator.
| Device ID | K063759 |
| 510k Number | K063759 |
| Device Name: | HEATMARKER TIME TEMPERATURE INDICATOR |
| Classification | Indicator, Physical/chemical, Storage Temperature |
| Applicant | TEMPTIME CORPORATION 116 AMERICAN ROAD Morris Plains, NJ 07950 |
| Contact | Richard Phillips |
| Correspondent | Richard Phillips TEMPTIME CORPORATION 116 AMERICAN ROAD Morris Plains, NJ 07950 |
| Product Code | OCI |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-19 |
| Decision Date | 2007-08-15 |
| Summary: | summary |