Submission Details
| 510(k) Number | K962655 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 08, 1996 |
| Decision Date | January 27, 1997 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
Cleared
Traditional
ANEROID AND MERCURIAL SPHYGMOMANOMETERS
Jan 1997
Decision
203d
Days
Class 2
Risk
About This 510(k) Submission
K962655 is an FDA 510(k) clearance for the ANEROID AND MERCURIAL SPHYGMOMANOMETERS, a Blood Pressure Cuff (Class II — Special Controls, product code DXQ), submitted by American Diagnostic Corp. (West Babylon, US). The FDA issued a Cleared decision on January 27, 1997, 203 days after receiving the submission on July 8, 1996. 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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