The following data is part of a premarket notification filed by Rtsafe, Inc. with the FDA for Pseudo-patient.
| Device ID | K180697 |
| 510k Number | K180697 |
| Device Name: | Pseudo-Patient |
| Classification | Accelerator, Linear, Medical |
| Applicant | RTsafe, Inc. 342 Regent Circle San Antonio, TX 78231 |
| Contact | Dimitris Makris |
| Correspondent | Jennifer Palinchik JALEX Medical, LLC. 30311 Clemens Rd. Suite #5D Westlake, OH 44145 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-16 |
| Decision Date | 2018-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001523218 | K180697 | 000 |
| 00860001523201 | K180697 | 000 |