The following data is part of a premarket notification filed by Suzhou 66 Vision Tech Co., Ltd. with the FDA for 66 Vision Tech Ophthalmoscope, Models Yz6e, Yz6f, Yz6g, Yz11, Yz11c, Yz11d, Yz25a.
| Device ID | K052599 |
| 510k Number | K052599 |
| Device Name: | 66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A |
| Classification | Ophthalmoscope, Battery-powered |
| Applicant | SUZHOU 66 VISION TECH CO., LTD. 600/8/503 LIUZHOU ROAD Shanghai, CN 200233 |
| Contact | Gong Bo |
| Correspondent | Gong Bo SUZHOU 66 VISION TECH CO., LTD. 600/8/503 LIUZHOU ROAD Shanghai, CN 200233 |
| Product Code | HLJ |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-21 |
| Decision Date | 2006-11-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851158007386 | K052599 | 000 |
| 00851158007379 | K052599 | 000 |