Submission Details
| 510(k) Number | K182934 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 22, 2018 |
| Decision Date | February 12, 2019 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
FORA P100 Blood Pressure Monitoring System
Feb 2019
Decision
113d
Days
Class 2
Risk
About This 510(k) Submission
K182934 is an FDA 510(k) clearance for the FORA P100 Blood Pressure Monitoring System, a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on February 12, 2019, 113 days after receiving the submission on October 22, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.
Device Classification
| Product Code | DXN — System, Measurement, Blood-pressure, Non-invasive |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1130 |
Manufacturer
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