The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Hydrogen Spectroscopy Option-probe #m1040hs/ht.
| Device ID | K930265 |
| 510k Number | K930265 |
| Device Name: | HYDROGEN SPECTROSCOPY OPTION-PROBE #M1040HS/HT |
| Classification | System, Nuclear Magnetic Resonance Spectroscopic |
| Applicant | GE MEDICAL SYSTEMS PO BOX 414 Milwaukee, WI 53201 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GE MEDICAL SYSTEMS PO BOX 414 Milwaukee, WI 53201 |
| Product Code | LNI |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-19 |
| Decision Date | 1995-04-25 |