The following data is part of a premarket notification filed by Portavision Medical Llc with the FDA for Pvmed Ddr 2430t.
Device ID | K133524 |
510k Number | K133524 |
Device Name: | PVMED DDR 2430T |
Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
Applicant | PORTAVISION MEDICAL LLC 5401 COCOS PLUMOSAS DRIVE Kenner, LA 70065 |
Contact | Terry Ancar |
Correspondent | Terry Ancar PORTAVISION MEDICAL LLC 5401 COCOS PLUMOSAS DRIVE Kenner, LA 70065 |
Product Code | MQB |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-11-15 |
Decision Date | 2014-04-16 |