The following data is part of a premarket notification filed by Fudakang Industries Co., Ltd with the FDA for Digital Thermometer, Models Bt-a11cn, Bt-a21cn, Bt-a41cn.
| Device ID | K101387 |
| 510k Number | K101387 |
| Device Name: | DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CN |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | FUDAKANG INDUSTRIES CO., LTD ROOM 2706 , BLOCK A ZHONGFANG JIN YUAN BLDG, XINWEN RD Shenzhen, Guangdon, CN 518034 |
| Contact | Stephen Ling |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-05-18 |
| Decision Date | 2010-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884392625027 | K101387 | 000 |
| 20810038630810 | K101387 | 000 |
| 10810038630790 | K101387 | 000 |
| 06955647600011 | K101387 | 000 |
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| 00851908007222 | K101387 | 000 |
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| 10859020006434 | K101387 | 000 |
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| 00859020006017 | K101387 | 000 |
| 00859020006178 | K101387 | 000 |
| 20852982006358 | K101387 | 000 |
| 00782905402256 | K101387 | 000 |
| 00739810210216 | K101387 | 000 |
| 00739810205113 | K101387 | 000 |
| 00738629168534 | K101387 | 000 |
| 10850632007581 | K101387 | 000 |
| 10891040701111 | K101387 | 000 |
| 00884392945411 | K101387 | 000 |