The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Cardiac Phased Array Coil.
| Device ID | K971667 |
| 510k Number | K971667 |
| Device Name: | CARDIAC PHASED ARRAY COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | GE MEDICAL SYSTEMS P.O. BOX 414 Milwaukee, WI 53188 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GE MEDICAL SYSTEMS P.O. BOX 414 Milwaukee, WI 53188 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-06 |
| Decision Date | 1997-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682121088 | K971667 | 000 |
| 00840682121033 | K971667 | 000 |