The following data is part of a premarket notification filed by Fora Care Inc. with the FDA for Fora P30 Plus Multi-mode Blood Pressure Monitoring System.
| Device ID | K110044 |
| 510k Number | K110044 |
| Device Name: | FORA P30 PLUS MULTI-MODE BLOOD PRESSURE MONITORING SYSTEM |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | FORA CARE INC. 3F, 5F, 6F, NO.127, WUGONG 2ND RD., WUGU TOWNSHIP Taipei County, TW 24888 |
| Contact | Teling Hsu |
| Correspondent | Teling Hsu FORA CARE INC. 3F, 5F, 6F, NO.127, WUGONG 2ND RD., WUGU TOWNSHIP Taipei County, 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 | 2011-01-06 |
| Decision Date | 2011-07-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816042013058 | K110044 | 000 |
| 00816042013867 | K110044 | 000 |
| 00816042015083 | K110044 | 000 |