The following data is part of a premarket notification filed by Mobius Medical Systems, Lp with the FDA for Doselab Pro.
| Device ID | K141230 |
| 510k Number | K141230 |
| Device Name: | DOSELAB PRO |
| Classification | Accelerator, Linear, Medical |
| Applicant | MOBIUS MEDICAL SYSTEMS, LP 5012 TAMARISK ST. Bellaire, TX 77401 |
| Contact | Stan Eshelman |
| Correspondent | Stan Eshelman MOBIUS MEDICAL SYSTEMS, LP 5012 TAMARISK ST. Bellaire, TX 77401 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-13 |
| Decision Date | 2014-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00899475002417 | K141230 | 000 |