The following data is part of a premarket notification filed by Omega Medical Imaging, Inc. with the FDA for Cs-series-fp.
| Device ID | K100102 |
| 510k Number | K100102 |
| Device Name: | CS-SERIES-FP |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | OMEGA MEDICAL IMAGING, INC. 675 HICKMAN CIRCLE Sanford, FL 32771 |
| Contact | James Princehorn |
| Correspondent | James Princehorn OMEGA MEDICAL IMAGING, INC. 675 HICKMAN CIRCLE Sanford, FL 32771 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | MQB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-13 |
| Decision Date | 2010-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853901007001 | K100102 | 000 |
| 00853901007018 | K100102 | 000 |