The following data is part of a premarket notification filed by Oncology Data Systems, Inc. with the FDA for Mucheck V8.
| Device ID | K091602 |
| 510k Number | K091602 |
| Device Name: | MUCHECK V8 |
| Classification | Accelerator, Linear, Medical |
| Applicant | ONCOLOGY DATA SYSTEMS, INC. 1601 SW 89TH STREET BUILDING E-100 Oklahoma City, OK 73159 |
| Contact | Vince Ruminer |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-06-03 |
| Decision Date | 2009-06-18 |
| Summary: | summary |