Submission Details
| 510(k) Number | K110775 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 21, 2011 |
| Decision Date | May 13, 2011 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
ELECTRONIC SPHYGMOMANOMETER
May 2011
Decision
53d
Days
Class 2
Risk
About This 510(k) Submission
K110775 is an FDA 510(k) clearance for the ELECTRONIC SPHYGMOMANOMETER, a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Contec Medical Systems Co.,Ltd (Shanghai, CN). The FDA issued a Cleared decision on May 13, 2011, 53 days after receiving the submission on March 21, 2011. 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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