The following data is part of a premarket notification filed by Wenzhou Bokang Instrument Co.,ltd with the FDA for Aneroid Sphygmomanometer, Model Bk2002.
| Device ID | K043286 |
| 510k Number | K043286 |
| Device Name: | ANEROID SPHYGMOMANOMETER, MODEL BK2002 |
| Classification | Blood Pressure Cuff |
| Applicant | WENZHOU BOKANG INSTRUMENT CO.,LTD 4413 GLENDALE ST. Metairie, LA 70006 |
| Contact | Zhang Jian |
| Correspondent | Tzu-wei Li CENTER FOR MEASUREMENT STANDARDS OF INDUSTRIAL BLDG. 16, 321 KUANG FU RD,SEC2 Hsinchu,, TW |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-11-26 |
| Decision Date | 2005-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616784709833 | K043286 | 000 |
| 00616784709710 | K043286 | 000 |
| 00811382013775 | K043286 | 000 |
| 00811382010682 | K043286 | 000 |
| 00811382010675 | K043286 | 000 |
| 00811382010668 | K043286 | 000 |
| 00811382011450 | K043286 | 000 |
| 00811382010781 | K043286 | 000 |
| 00811382010767 | K043286 | 000 |