The following data is part of a premarket notification filed by Medimaging Integrated Solution Inc. (miis) with the FDA for Miis Horus Scope Dpt 100.
| Device ID | K181260 |
| 510k Number | K181260 |
| Device Name: | MiiS Horus Scope DPT 100 |
| Classification | Tonometer, Ac-powered |
| Applicant | Medimaging Integrated Solution Inc. (MiiS) 1F, No.7, R&D Rd. II Hsinchu Science Park Hsinchu, CN 30076 |
| Contact | Chih-lu Hsu |
| Correspondent | Chih-lu Hsu Medimaging Integrated Solution Inc. (MiiS) 1F, No.7, R&D Rd. II Hsinchu Science Park Hsinchu, CN 30076 |
| Product Code | HKX |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-11 |
| Decision Date | 2019-06-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M6333974340 | K181260 | 000 |