Submission Details
| 510(k) Number | K112544 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 01, 2011 |
| Decision Date | November 22, 2011 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
UNIMED BLOOD PRESSURE CUFF
Nov 2011
Decision
82d
Days
Class 2
Risk
About This 510(k) Submission
K112544 is an FDA 510(k) clearance for the UNIMED BLOOD PRESSURE CUFF, a Blood Pressure Cuff (Class II — Special Controls, product code DXQ), submitted by Unimed Medical Supplies, Inc. (Shenzhen, Guangdong, CN). The FDA issued a Cleared decision on November 22, 2011, 82 days after receiving the submission on September 1, 2011. 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. |
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