Pressurometer II
by Del Mar Avionics 510(k)
Active
510(k) K771500
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK771500 | Date16 Aug 1977 | 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- Withdrawn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, 6 Oct 2026
The PRESSUROMETER II is an automatic ambulatory blood pressure-recording device intended for cardiovascular monitoring. It is designed to record blood pressure and heart rate data during routine daily activities. The device operates as a portable unit for continuous measurement outside of clinical settings.
The PRESSUROMETER II was manufactured by Del Mar Avionics and submitted for regulatory review under FDA 510(k) number K771500. It is classified under product code DXN and falls within the cardiovascular medical specialty. The device received a substantially equivalent determination on August 16, 1977, and is regulated under 870.1130 as a class II medical device.
Other devices from Del Mar Avionics
Questions
AI-generated answers, 6 Oct 2026
What is the PRESSUROMETER II used for?
The PRESSUROMETER II is an automatic ambulatory blood pressure-recording device designed for cardiovascular monitoring. It records blood pressure and heart rate data during routine daily activities, allowing for continuous measurement outside of clinical settings.
How is the PRESSUROMETER II supplied?
The PRESSUROMETER II is supplied as a portable unit that can be worn by patients during their normal daily activities. It is designed for automatic operation, recording blood pressure and heart rate data continuously without requiring constant supervision.
What is the regulatory status of the PRESSUROMETER II?
The PRESSUROMETER II received FDA 510(k) clearance with number K771500 on August 16, 1977. It was determined to be substantially equivalent and is classified as a class II medical device under product code DXN within the cardiovascular specialty.
Can the PRESSUROMETER II be reused?
The device description does not specify whether the PRESSUROMETER II is designed for single-use or multiple uses. As a blood pressure monitoring device intended for ambulatory use, it would typically be designed for repeated measurements but may have specific reuse limitations that should be confirmed with the manufacturer.