Norelco Electronic Digital Blood Press
by North American Philips Corp. 510(k)
Active
510(k) K830684
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK830684 | Date18 May 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DXN
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1130
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Norelco Electronic Digital Blood Pressure Monitor is a noninvasive blood pressure measurement device classified under product code DXN. It measures systolic, diastolic, and mean arterial pressure by utilizing transducers placed on the body surface, providing automated digital readings for clinical assessment.
This device is intended for single-use or reusable clinical settings, depending on manufacturer guidelines, and requires no special sterility conditions. It is not MRI-compatible and is supplied as a standalone unit. The device holds an FDA 510(k) clearance (K830684) under the Cardiovascular advisory committee, with a decision of Substantially Equivalent. No additional regulatory markings or certifications are stated.
Other devices from North American Philips Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Norelco Electronic Digital Blood Pressure Monitor used for?
This device is designed for noninvasive blood pressure measurement in clinical settings. It automatically provides digital readings of systolic, diastolic, and mean arterial pressure by using transducers placed on the body surface. This helps clinicians assess cardiovascular health and monitor patients efficiently.
How is the Norelco Electronic Digital Blood Pressure Monitor supplied?
The device is supplied as a standalone unit, meaning it does not require additional accessories or attachments for basic operation. It is intended for use in clinical environments, where it can be either single-use or reusable, depending on facility guidelines and infection control protocols.
Does the Norelco Electronic Digital Blood Pressure Monitor require special sterility conditions?
No special sterility conditions are specified for this device. However, if used in reusable settings, it must follow standard clinical disinfection and sterilization protocols to ensure patient safety and device integrity between uses.
Is the Norelco Electronic Digital Blood Pressure Monitor MRI-compatible?
No, the device is explicitly stated as not MRI-compatible. This means it should not be used near MRI machines, as exposure to magnetic fields could potentially damage the device or compromise its performance.
What regulatory clearance does the Norelco Electronic Digital Blood Pressure Monitor hold?
The device holds an FDA 510(k) clearance (K830684) under the Cardiovascular advisory committee. The clearance decision was determined to be ‘Substantially Equivalent’ to a predicate device, meaning it was found to have the same intended use, technological characteristics, and performance as the predicate without clinically significant differences.