ACCUDXA2
Densitometer, Bone
LONE OAK MEDICAL TECHNOLOGIES, LLC
The following data is part of a premarket notification filed by Lone Oak Medical Technologies, Llc with the FDA for Accudxa2.
Pre-market Notification Details
| Device ID | K113616 |
| 510k Number | K113616 |
| Device Name: | ACCUDXA2 |
| Classification | Densitometer, Bone |
| Applicant | LONE OAK MEDICAL TECHNOLOGIES, LLC 3805 OLD EASTON ROAD Doylestown, PA 18902 |
| Contact | David Comley |
| Correspondent | David Comley LONE OAK MEDICAL TECHNOLOGIES, LLC 3805 OLD EASTON ROAD Doylestown, PA 18902 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-07 |
| Decision Date | 2012-04-27 |
| Summary: | summary |
Trademark Results [ACCUDXA2]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACCUDXA2 85623997 4360095 Live/Registered |
Lone Oak Medical Technologies, LLC 2012-05-14 |
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