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 |