The following data is part of a premarket notification filed by Zargis Medical Corp. with the FDA for Modification To Zargis Acoustic Cardioscan (zac).
| Device ID | K042128 |
| 510k Number | K042128 |
| Device Name: | MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC) |
| Classification | Stethoscope, Electronic |
| Applicant | ZARGIS MEDICAL CORP. 755 COLLEGE RD. EAST Princeton, NJ 08540 |
| Contact | Donald Brooks |
| Correspondent | Donald Brooks ZARGIS MEDICAL CORP. 755 COLLEGE RD. EAST 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 | 2004-08-06 |
| Decision Date | 2004-09-08 |
| Summary: | summary |