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 |
| D090101289030 | K040691 | 000 |