DSJ · Alarm, Blood-Pressure
Cardiovascular · 21 CFR 870.1100 · Class 2
Overview
| Product Code | DSJ |
|---|---|
| Device Name | Alarm, Blood-Pressure |
| Regulation | 21 CFR 870.1100 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A blood pressure alarm is a device that accepts the signal from a blood pressure transducer amplifier, processes the signal, and emits an alarm when the blood pressure falls outside a pre-set upper or lower limit.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K190624 | EarlyVue VS30 | Philips Medizin Systeme Boeblingen GmbH | Oct 27, 2019 | SESE |
| K163649 | SureSigns VS3; SureSigns VS4 | Philips Medical Systems | Mar 31, 2017 | SESE |
| K151761 | SureSigns VS3, SureSigns VS4 | Phillips Medical Systems | Sep 29, 2015 | SESE |
| K133961 | SURESIGNS VS3, SURESIGNS VS4 | Philips Medical Systems | Jun 26, 2014 | SESE |
| K960916 | SAMS 8000 CARDIOPLEGIA MONITOR | 3M Health Care, Sarns | Jun 4, 1996 | SESE |
| K910262 | KELLER VITAL SIGNS MONITOR - KMS-890 | Keller Medical Specialties Products, Inc. | Apr 1, 1991 | SESE |
Top Applicants
- Philips Medical Systems — 2 clearances
- 3M Health Care, Sarns — 1 clearance
- Keller Medical Specialties Products, Inc. — 1 clearance
- Philips Medizin Systeme Boeblingen GmbH — 1 clearance
- Phillips Medical Systems — 1 clearance
