K930265 is an FDA 510(k) clearance for the HYDROGEN SPECTROSCOPY OPTION-PROBE #M1040HS/HT. This device is classified as a System, Nuclear Magnetic Resonance Spectroscopic (Class II - Special Controls, product code LNI).
Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on April 25, 1995, 826 days after receiving the submission on January 19, 1993.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K930265 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 1993 |
| Decision Date | April 25, 1995 |
| Days to Decision | 826 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LNI - System, Nuclear Magnetic Resonance Spectroscopic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1000 |