The following data is part of a premarket notification filed by General Medical Merate S.p.a. with the FDA for Opera Swing.
| Device ID | K140380 |
| 510k Number | K140380 |
| Device Name: | OPERA SWING |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | GENERAL MEDICAL MERATE S.P.A. 110 E. GRANADA BLVD SUITE 209 Ormond Beach, FL 32176 |
| Contact | Berthoin Claude |
| Correspondent | Berthoin Claude GENERAL MEDICAL MERATE S.P.A. 110 E. GRANADA BLVD SUITE 209 Ormond Beach, FL 32176 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-14 |
| Decision Date | 2014-09-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08054890480048 | K140380 | 000 |
| 08054890480031 | K140380 | 000 |
| 08054890480017 | K140380 | 000 |
| 08054890480000 | K140380 | 000 |