Definition: The Intended Use For The Reprocessed/reused Blood Pressure Cuff Is Use In Manual Measurement And Automatic Non-invasive Blood Pressure Monitoring By Properly Trained Personnel. Complete Inflation Systems Are Designed For Use With Manometers During Ma
Device Type ID | 917 |
Device Name | Reprocessed Blood Pressure Cuff |
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 | NPP |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 917 |
Device | Reprocessed Blood Pressure Cuff |
Product Code | NPP |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Blood Pressure Cuff. |
CFR Regulation Number | 870.1120 [🔎] |