The following data is part of a premarket notification filed by Dongguan Ageless Health Industrial Co., Ltd with the FDA for Ageless Health Medical Digital Thermometer.
| Device ID | K152508 |
| 510k Number | K152508 |
| Device Name: | Ageless Health Medical Digital Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | DONGGUAN AGELESS HEALTH INDUSTRIAL CO., LTD 3/F, A1 BLDG, DONGSHEN SIMA INDUSTRIAL AREA, NO.33 SHENBEI ROAD Dongguan, CN 523560 |
| Contact | Victor Wan |
| Correspondent | Cecilia Ceng GUANGZHOU GLOMED BIOLOGICAL TECHNOLOGY CO., LTD SUIT 306, KECHENG MANSION. NO.121 SCIENCE ROAD, GUANGZHOU SCIENCE PARK Guangzhou, CN 510663 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-02 |
| Decision Date | 2015-12-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06958682800354 | K152508 | 000 |
| 30193489010415 | K152508 | 000 |
| 06958682800286 | K152508 | 000 |
| 06958682800293 | K152508 | 000 |
| 06958682800309 | K152508 | 000 |
| 06958682800316 | K152508 | 000 |
| 06958682800323 | K152508 | 000 |
| 06958682800330 | K152508 | 000 |
| 06958682800347 | K152508 | 000 |
| 10888277701489 | K152508 | 000 |