The following data is part of a premarket notification filed by Win-us Technology Co., Ltd. with the FDA for Intra Oral Camera System & Accessories, Model Win-100d.
Device ID | K040691 |
510k Number | K040691 |
Device Name: | INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D |
Classification | Unit, Operative Dental |
Applicant | WIN-US TECHNOLOGY CO., LTD. 1308 MORNINGSIDE PARK DRIVE Alpharetta, GA 30022 |
Contact | Jay Mansour |
Product Code | EIA |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2004-03-17 |
Decision Date | 2004-03-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
EKAV101149960 | K040691 | 000 |
EKAV101149840 | K040691 | 000 |
EKAV100719700 | K040691 | 000 |
EKAV100719690 | K040691 | 000 |
EKAV100713330 | K040691 | 000 |
EKAV082243310 | K040691 | 000 |
EKAV101289070 | K040691 | 000 |
EKAV101289030 | K040691 | 000 |