The following data is part of a premarket notification filed by Orthogrid Systems Inc. with the FDA for Phantommsk.
Device ID | K182332 |
510k Number | K182332 |
Device Name: | PhantomMSK |
Classification | System, Image Processing, Radiological |
Applicant | OrthoGrid Systems Inc. 3216 South Highland, Suite 202 Salt Lake City, UT 84106 |
Contact | Sebastian Edin |
Correspondent | Sebastian Edin OrthoGrid Systems Inc. 3216 South Highland, Suite 202 Salt Lake City, UT 84106 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-08-28 |
Decision Date | 2019-02-15 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PHANTOMMSK 88823232 not registered Live/Pending |
OrthoGrid Systems, Inc. 2020-03-05 |