The following data is part of a premarket notification filed by Medtec, Inc. Dba Civco Medical Solutions And Civco with the FDA for C-qual M™ Breastboard; Monarch™ Overhead Arm Positioner.
| Device ID | K211001 |
| 510k Number | K211001 |
| Device Name: | C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner |
| Classification | Accelerator, Linear, Medical |
| Applicant | MEDTEC, Inc. Dba CIVCO Medical Solutions And CIVCO Radiotherapy 1401 8th Street SE Orange City, IA 51041 |
| Contact | Alena Newgren |
| Correspondent | Alena Newgren MEDTEC, Inc. Dba CIVCO Medical Solutions And CIVCO 1401 8th Street SE Orange City, IA 51041 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-02 |
| Decision Date | 2021-05-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841439113455 | K211001 | 000 |
| 00841439114155 | K211001 | 000 |
| 00841439114148 | K211001 | 000 |
| 00841439114131 | K211001 | 000 |
| 00841439114124 | K211001 | 000 |
| 00841439114483 | K211001 | 000 |
| 00841439114490 | K211001 | 000 |