The following data is part of a premarket notification filed by Zargis Medical Corp. with the FDA for Zargis Acoustic Cardioscan (zac), Model Zac 6.28.
| Device ID | K060197 |
| 510k Number | K060197 |
| Device Name: | ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28 |
| Classification | Stethoscope, Electronic |
| Applicant | ZARGIS MEDICAL CORP. 2 RESEARCH WAY Princeton, NJ 08540 |
| Contact | John Kallassy |
| Correspondent | John Kallassy ZARGIS MEDICAL CORP. 2 RESEARCH WAY Princeton, NJ 08540 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-26 |
| Decision Date | 2006-03-29 |
| Summary: | summary |