Model 509A Physiocorder Ambulatory Recorder
by Del Mar Avionics 510(k)
Active
510(k) K854269
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK854269 | Date11 Apr 1986 | 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- Withdrawn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
- DSH
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2800
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The device is a recorder, magnetic tape, medical, classified as a cardiovascular device under regulation number 870.2800. It is designed for ambulatory physiological recording using magnetic tape technology.
It was cleared via the FDA 510(k) process under K854269 with a traditional clearance type and substantially equivalent decision. The device is manufactured by Del Mar Avionics in Irvine, California, and is intended for use in cardiovascular monitoring applications as indicated by its product code DSH and advisory committee classification.
Other devices from Del Mar Avionics
Questions
AI-generated answers, 21 Sep 2026
What is the MODEL 509A PHYSIOCORDER used for?
The MODEL 509A PHYSIOCORDER is designed for ambulatory physiological recording using magnetic tape technology, specifically intended for cardiovascular monitoring applications as indicated by its product code DSH and classification under regulation number 870.2800.
How was the MODEL 509A PHYSIOCORDER cleared for market?
The device was cleared via the FDA 510(k) process under submission K854269 with a traditional clearance type and a substantially equivalent decision, meaning it was found to be substantially equivalent to a legally marketed predicate device.
Who manufactures the MODEL 509A PHYSIOCORDER and where is it made?
The MODEL 509A PHYSIOCORDER is manufactured by Del Mar Avionics at their facility located at 1601 Alton Ave., Irvine, California, 92606, United States.