The following data is part of a premarket notification filed by General Electric Co. with the FDA for General Purpose Flex Coil.
| Device ID | K923264 |
| 510k Number | K923264 |
| Device Name: | GENERAL PURPOSE FLEX COIL |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-02 |
| Decision Date | 1992-09-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682116145 | K923264 | 000 |