Modification to Zargis Acoustic Cardioscan (ZAC)
by Zargis Medical Corp. 510(k)
Active
510(k) K042128
Overview
This device is an electronic stethoscope, specifically a modification to the Zargis Acoustic Cardioscan (ZAC), intended to provide support to the physician in the evaluation of heart sounds in patients. It is classified as a Class II medical device under FDA regulation 870.1875 with product code DQD.
The device was cleared via the FDA 510(k) process under submission K042128 on September 8, 2004, and is substantially equivalent to a predicate device. It is manufactured by Zargis Medical Corp. in Princeton, New Jersey, and is designated for cardiovascular use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK042128 | Date8 Sep 2004 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- DQD
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1875
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Zargis Medical Corp.
Questions
What is the Modification to Zargis Acoustic Cardioscan (ZAC) used for?
It is an electronic stethoscope intended to provide support to physicians in the evaluation of heart sounds in patients, specifically designed for cardiovascular assessment as indicated in its FDA 510(k) submission.
How was the Modification to Zargis Acoustic Cardioscan (ZAC) cleared for market?
The device was cleared via the FDA 510(k) process under submission K042128 on September 8, 2004, as substantially equivalent to a predicate device, which is the regulatory pathway referenced in its authorization data.
Who manufactures the Modification to Zargis Acoustic Cardioscan (ZAC) and where is it located?
The device is manufactured by Zargis Medical Corp., with its address listed as 755 College Rd. E., Princeton, NJ 08540, United States, as specified in the device’s registration and contact details.