The following data is part of a premarket notification filed by Fora Care Inc. with the FDA for Fora Care Blood Pressure Monitoring System.
| Device ID | K133588 |
| 510k Number | K133588 |
| Device Name: | FORA CARE BLOOD PRESSURE MONITORING SYSTEM |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | FORA CARE INC. 6F, NO.127, WUGONG 2ND RD WUGU DISTRICT New Taipei City, TW 24888 |
| Contact | Sharon Peng |
| Correspondent | Sharon Peng FORA CARE INC. 6F, NO.127, WUGONG 2ND RD WUGU DISTRICT New Taipei City, TW 24888 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-21 |
| Decision Date | 2014-04-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816042011917 | K133588 | 000 |