| Device Type ID | 769 |
| Device Name | Alarm, Blood-pressure |
| Regulation Description | Blood Pressure Alarm. |
| 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 | 870.1100 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DSJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 769 |
| Device | Alarm, Blood-pressure |
| Product Code | DSJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Blood Pressure Alarm. |
| CFR Regulation Number | 870.1100 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
PHILIPS MEDICAL SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PHILLIPS MEDICAL SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Monitor | 2 |
Device Operates Differently Than Expected | 2 |
PC (Printed Circuit) Board | 1 |
No Display / Image | 1 |
| Total Device Problems | 6 |