The following data is part of a premarket notification filed by Resonance Health Analysis Services Pty Ltd with the FDA for Hepafat Scan.
| Device ID | K122035 |
| 510k Number | K122035 |
| Device Name: | HEPAFAT SCAN |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | RESONANCE HEALTH ANALYSIS SERVICES PTY LTD 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Greg Holland |
| Correspondent | Greg Holland RESONANCE HEALTH ANALYSIS SERVICES PTY LTD 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-11 |
| Decision Date | 2013-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09355529000040 | K122035 | 000 |