The following data is part of a premarket notification filed by Ge Medical Systems Scs with the FDA for Discovery Igs 740.
| Device ID | K133278 |
| 510k Number | K133278 |
| Device Name: | DISCOVERY IGS 740 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | GE MEDICAL SYSTEMS SCS 283 RUE DE LA MINIERE Buc, FR 78530 |
| Contact | Michel Genuer |
| Correspondent | Michel Genuer GE MEDICAL SYSTEMS SCS 283 RUE DE LA MINIERE Buc, FR 78530 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-24 |
| Decision Date | 2014-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682110693 | K133278 | 000 |