The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Gyrex 2t-prestige.
| Device ID | K970005 |
| 510k Number | K970005 |
| Device Name: | GYREX 2T-PRESTIGE |
| Classification | System, Nuclear Magnetic Resonance Spectroscopic |
| Applicant | ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack, NJ 07601 |
| Contact | Thomas J Spackman |
| Correspondent | Thomas J Spackman ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack, NJ 07601 |
| Product Code | LNI |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-02 |
| Decision Date | 1997-03-28 |
| Summary: | summary |