The following data is part of a premarket notification filed by Pointnix Co., Ltd with the FDA for Point 500 Hd Point500c Hd.
Device ID | K121800 |
510k Number | K121800 |
Device Name: | POINT 500 HD POINT500C HD |
Classification | System, X-ray, Extraoral Source, Digital |
Applicant | POINTNIX CO., LTD 55 NORTHERN BLVD Great Neck, NY 11021 |
Contact | Jigar Shah |
Correspondent | Jigar Shah POINTNIX CO., LTD 55 NORTHERN BLVD Great Neck, NY 11021 |
Product Code | MUH |
CFR Regulation Number | 872.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-06-19 |
Decision Date | 2013-01-24 |
Summary: | summary |