The following data is part of a premarket notification filed by Rossmax Internationl Ltd. with the FDA for Rossmax Digital Sphygmomanometer Mandaus Ii.
| Device ID | K053006 |
| 510k Number | K053006 |
| Device Name: | ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II |
| Classification | Blood Pressure Cuff |
| Applicant | ROSSMAX INTERNATIONL LTD. 12F, NO. 189, KANG CHIEN RD. Taipei, TW 114 |
| Contact | Yolanda Lin |
| Correspondent | 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 | 2005-10-26 |
| Decision Date | 2006-02-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00634782570613 | K053006 | 000 |
| 00634782564995 | K053006 | 000 |
| 00634782565008 | K053006 | 000 |
| 00634782565015 | K053006 | 000 |
| 00634782565022 | K053006 | 000 |
| 00634782565039 | K053006 | 000 |
| 00634782565046 | K053006 | 000 |
| 00634782565053 | K053006 | 000 |
| 00634782565060 | K053006 | 000 |
| 00634782565077 | K053006 | 000 |
| 00634782570330 | K053006 | 000 |
| 00634782570347 | K053006 | 000 |
| 00634782570354 | K053006 | 000 |
| 00634782570606 | K053006 | 000 |
| 00634782564988 | K053006 | 000 |