The following data is part of a premarket notification filed by Shanghai Mediworks Precision Instruments Co. Ltd. with the FDA for Applanation Tonometer.
| Device ID | K142263 |
| 510k Number | K142263 |
| Device Name: | Applanation Tonometer |
| Classification | Tonometer, Manual |
| 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 | HKY |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-14 |
| Decision Date | 2016-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945087517024 | K142263 | 000 |
| 06945087517017 | K142263 | 000 |
| 06945033902249 | K142263 | 000 |
| 06945087580011 | K142263 | 000 |
| 06945087580004 | K142263 | 000 |