The following data is part of a premarket notification filed by Yu Long Sheng Technology Co., Ltd with the FDA for Yu Long Sheng Disposable Thermometer Sheaths, Models Yls-01 And Yls-02.
| Device ID | K102508 |
| 510k Number | K102508 |
| Device Name: | YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | YU LONG SHENG TECHNOLOGY CO., LTD NO. 15, ALLEY 71, CHENPING 1ST BEITUN DISTRICT Taichung, TW 406 |
| Contact | Tony C Chang |
| Correspondent | Tony C Chang YU LONG SHENG TECHNOLOGY CO., LTD NO. 15, ALLEY 71, CHENPING 1ST BEITUN DISTRICT Taichung, TW 406 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-01 |
| Decision Date | 2011-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00634782562762 | K102508 | 000 |
| 10767056182506 | K102508 | 000 |
| 10767056181509 | K102508 | 000 |
| 30096295130066 | K102508 | 000 |