The following data is part of a premarket notification filed by Intelligent Product Limited Co. with the FDA for Pro-flex, Digital Thermometer With Flexible Probe.
| Device ID | K961357 |
| 510k Number | K961357 |
| Device Name: | PRO-FLEX, DIGITAL THERMOMETER WITH FLEXIBLE PROBE |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | INTELLIGENT PRODUCT LIMITED CO. 463 N. OREM BLVD. Orem, UT 84057 |
| Contact | Matthew Kho |
| Correspondent | Matthew Kho INTELLIGENT PRODUCT LIMITED CO. 463 N. OREM BLVD. Orem, UT 84057 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-08 |
| Decision Date | 1996-08-16 |
| Summary: | summary |