Definition: Device Is A Replacement Cuff To Be Used In Conjunction With A Non-invasive Blood Pressure Monitor. Together The Devices Determine Blood Pressures And Heart Rate. This Particular Cuff Contains An Embedded Antimicrobial. A Blood Pressure Cuff Is A Devi
| Device Type ID | 927 |
| Device Name | Antimicrobial Blood Pressure Cuff |
| Physical State | The Device Is A Typically A Textile Enfolded Over An Inflatable Bladder. |
| Technical Method | The Blood Pressure Cuff Wraps Around The Subject's Arm Or Wrist And The Bladder Is Inflated. The Pressure From The Bladder Occludes The Artery. When The Pressure Is Slowly Released, The Korotkoff Sounds Or Oscillometric Wave Form Produced Is Interpre |
| Target Area | The Cuff Is Placed Either Over The Upper Arm, Wrist, Or Thigh. |
| Regulation Description | Blood Pressure Cuff. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1120 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OED |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 927 |
| Device | Antimicrobial Blood Pressure Cuff |
| Product Code | OED |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Blood Pressure Cuff. |
| CFR Regulation Number | 870.1120 [🔎] |