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 |