The following data is part of a premarket notification filed by Macromedics Bv with the FDA for Patient Positioning Devices.
| Device ID | K142420 |
| 510k Number | K142420 |
| Device Name: | Patient Positioning Devices |
| Classification | Accelerator, Linear, Medical |
| Applicant | MACROMEDICS BV Kouwe Hoek 18 Waddinxveen, NL 2741 |
| Contact | C De Keijzer |
| Correspondent | C De Keijzer MACROMEDICS BV Kouwe Hoek 18 Waddinxveen, NL 2741 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-28 |
| Decision Date | 2015-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08719425700960 | K142420 | 000 |
| 08719425700953 | K142420 | 000 |
| 08719425700946 | K142420 | 000 |
| 08719425700939 | K142420 | 000 |
| 08720168162328 | K142420 | 000 |
| 08720168162304 | K142420 | 000 |