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 |