The following data is part of a premarket notification filed by Shanghai Mediworks Precision Instruments Co., Ltd. with the FDA for Slit Lamp Microscope.
| Device ID | K152429 |
| 510k Number | K152429 |
| Device Name: | Slit Lamp Microscope |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO., LTD. Zone A, 2nd Floor, No. 69, Lane 1985, Chunshen Road Minhang District, Shanghai, CN 200237 |
| Contact | Weida Zhan |
| Correspondent | Weida Zhan SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO., LTD. Zone A, 2nd Floor, No. 69, Lane 1985, Chunshen Road Minhang District, Shanghai, CN 200237 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-26 |
| Decision Date | 2016-05-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945087539026 | K152429 | 000 |
| 06945087535073 | K152429 | 000 |
| 06945087535066 | K152429 | 000 |
| 06945087590027 | K152429 | 000 |
| 06945087590010 | K152429 | 000 |
| 06945087525012 | K152429 | 000 |
| 06945087525005 | K152429 | 000 |
| 06945087500217 | K152429 | 000 |
| 06945087500057 | K152429 | 000 |
| 06945087545010 | K152429 | 000 |
| 06945087545027 | K152429 | 000 |
| 06945087539019 | K152429 | 000 |
| 06945087536025 | K152429 | 000 |
| 06945087536018 | K152429 | 000 |
| 06945087535035 | K152429 | 000 |
| 06945087528037 | K152429 | 000 |
| 06945087526026 | K152429 | 000 |
| 06945087526019 | K152429 | 000 |
| 06945087516010 | K152429 | 000 |
| 06945087500040 | K152429 | 000 |