Submission Details
| 510(k) Number | K102825 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 29, 2010 |
| Decision Date | March 02, 2011 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
BLOOD PRESSURE CUFF
Mar 2011
Decision
154d
Days
Class 2
Risk
About This 510(k) Submission
K102825 is an FDA 510(k) clearance for the BLOOD PRESSURE CUFF, a Blood Pressure Cuff (Class II — Special Controls, product code DXQ), submitted by APK Technology Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on March 2, 2011, 154 days after receiving the submission on September 29, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1120.
Device Classification
| Product Code | DXQ — Blood Pressure Cuff |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1120 |
| Definition | A Blood Pressure Cuff Is A Device That Has An Inflatable Bladder In An Elastic Sleeve (cuff) With A Mechanism For Inflating The Bladder. The Cuff Is Used To Determine A Subject's Blood Pressure. |
Manufacturer
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