The following data is part of a premarket notification filed by Truer Medical Inc. with the FDA for Skin Sensor Probe, General Purpose Probe, Tympanic Probe.
| Device ID | K101244 |
| 510k Number | K101244 |
| Device Name: | SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | TRUER MEDICAL INC. 1050 N BATAVIA STREET Orange, CA 92867 |
| Contact | Tim Truitt |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-05-04 |
| Decision Date | 2010-11-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30859290006145 | K101244 | 000 |
| 40859290006135 | K101244 | 000 |
| 00859290006120 | K101244 | 000 |
| 00859290006113 | K101244 | 000 |
| 00851450007121 | K101244 | 000 |
| 00851450007114 | K101244 | 000 |