Alarm, Blood-Pressure
The Blood-Pressure Alarm is a cardiovascular safety device used to alert clinical staff when a patient's blood pressure exceeds or falls below pre-set thresholds, enabling timely clinical intervention during patient monitoring. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DSJ and it is regulated under 21 CFR 870.1100 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DSJ
- Device Class
- FDA class 2
- Regulation Number
- 870.1100
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K190624 | EarlyVue VS30 | Oct 27, 2019 | Substantially Equivalent | Philips Medizin Systeme Boeblingen GmbH |
| K163649 | SureSigns VS3; SureSigns VS4 | Mar 31, 2017 | Substantially Equivalent | Philips Medical Systems |
| K151761 | SureSigns VS3, SureSigns VS4 | Sep 29, 2015 | Substantially Equivalent | Phillips Medical Systems |
| K133961 | SURESIGNS VS3, SURESIGNS VS4 | Jun 26, 2014 | Substantially Equivalent | Philips Medical Systems |
| K960916 | SAMS 8000 CARDIOPLEGIA MONITOR | Jun 04, 1996 | Substantially Equivalent | 3M Health Care, Sarns |
| K910262 | KELLER VITAL SIGNS MONITOR - KMS-890 | Apr 01, 1991 | Substantially Equivalent | Keller Medical Specialties Products, Inc. |
FEI Numbers
This FDA classification entry is associated with 42 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 42 registration numbers. Click on an entry to view related FDA registrations.