The following data is part of a premarket notification filed by Medtec Inc. Dba Civco Medical Solutions with the FDA for Bellyboard, Sbrt Accessories.
| Device ID | K121545 |
| 510k Number | K121545 |
| Device Name: | BELLYBOARD, SBRT ACCESSORIES |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MEDTEC INC. DBA CIVCO MEDICAL SOLUTIONS 1401 8TH STREET SE Orange City, IA 51041 |
| Contact | Amanda Stahle |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-05-25 |
| Decision Date | 2012-06-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841439101261 | K121545 | 000 |
| 00841439101254 | K121545 | 000 |
| 00841439100790 | K121545 | 000 |