The following data is part of a premarket notification filed by Biosound Esaote, Inc. with the FDA for Modification To E-scan.
| Device ID | K001894 |
| 510k Number | K001894 |
| Device Name: | MODIFICATION TO E-SCAN |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | BIOSOUND ESAOTE, INC. 8000 CASTLEWAY DR. Indianapolis, IN 46250 |
| Contact | Colleen Hittle |
| Correspondent | Colleen Hittle BIOSOUND ESAOTE, INC. 8000 CASTLEWAY DR. Indianapolis, IN 46250 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-21 |
| Decision Date | 2000-07-06 |