The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for 2t Prestige(100-6321-0107)/privilege(100-6326-0102)/gyrex V-ep(100-6327-0101).
| Device ID | K972592 |
| 510k Number | K972592 |
| Device Name: | 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101) |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack, NJ 07601 |
| Contact | Beny Sherer |
| Correspondent | Beny Sherer ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack, NJ 07601 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-11 |
| Decision Date | 1997-09-15 |
| Summary: | summary |