The following data is part of a premarket notification filed by Zargis Medical Corp. with the FDA for Zargis Acoustic Cardioscan.
| Device ID | K031517 |
| 510k Number | K031517 |
| Device Name: | ZARGIS ACOUSTIC CARDIOSCAN |
| Classification | Stethoscope, Electronic |
| Applicant | ZARGIS MEDICAL CORP. 755 COLLEGE RD. EAST Princeton, NJ 08540 |
| Contact | Shahram Hejazi |
| Correspondent | Shahram Hejazi ZARGIS MEDICAL CORP. 755 COLLEGE RD. EAST Princeton, NJ 08540 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-15 |
| Decision Date | 2004-05-26 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ZARGIS ACOUSTIC CARDIOSCAN 78301122 3030184 Dead/Cancelled |
ZARGIS MEDICAL CORP. 2003-09-16 |