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 |