The following data is part of a premarket notification filed by Phoenix Innovative Healthcare Manufacturers Pvt. Ltd. with the FDA for Phoenix Digital Thermometer.
| Device ID | K201032 |
| 510k Number | K201032 |
| Device Name: | Phoenix Digital Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Phoenix Innovative Healthcare Manufacturers Pvt. Ltd. EL-209 Shil Mahape Road Electronic Zone MIDC, TTC Industrial Area Mahape, Navi Mumbai, IN 400710 |
| Contact | Ramshankar Ghosh |
| Correspondent | Michael Stuart Phoenix Healthcare Solutions, LLC 2281 Griffin Road Fort Lauderdale, FL 33312 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-20 |
| Decision Date | 2021-10-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00360913521017 | K201032 | 000 |