The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Myospect, Myospect Es.
| Device ID | K212004 |
| 510k Number | K212004 |
| Device Name: | MyoSPECT, MyoSpect ES |
| Classification | System, Tomography, Computed, Emission |
| Applicant | GE Healthcare 4 Hayozma Street Tirat Hacarmel, IL 30200 |
| Contact | George Mashour |
| Correspondent | George Mashour GE Healthcare 4 Hayozma Street Tirat Hacarmel, IL 30200 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-28 |
| Decision Date | 2021-08-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195278421586 | K212004 | 000 |
| 00195278421579 | K212004 | 000 |
| 00195278722546 | K212004 | 000 |
| 00195278488626 | K212004 | 000 |
| 00195278488619 | K212004 | 000 |