The following data is part of a premarket notification filed by Takagi Seiko Co., Ltd. with the FDA for Z5 Slit Lamp Microscope, Z2 Slit Lamp Microscope.
| Device ID | K152535 |
| 510k Number | K152535 |
| Device Name: | Z5 Slit Lamp Microscope, Z2 Slit Lamp Microscope |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | TAKAGI SEIKO CO., LTD. 330-2 IWAHUNE, NAKANO-SHI, NAGANO-KEN Nagano, JP 383-8585 |
| Contact | Nagaike Yoshio |
| Correspondent | Nagaike Yoshio TAKAGI SEIKO CO., LTD. 330-2 IWAHUNE, NAKANO-SHI, NAGANO-KEN Nagano, JP 383-8585 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-04 |
| Decision Date | 2016-05-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06909071678450 | K152535 | 000 |
| 06909071678443 | K152535 | 000 |
| 06909071678436 | K152535 | 000 |
| 06909071678429 | K152535 | 000 |
| 04560323648434 | K152535 | 000 |
| 04560323648427 | K152535 | 000 |
| 04560323641121 | K152535 | 000 |
| 04560323641114 | K152535 | 000 |
| 04560323640940 | K152535 | 000 |