The following data is part of a premarket notification filed by Takagi Seiko Co.ltd. with the FDA for Marco Ultra M3, Marco Ultra M4.
| Device ID | K162636 |
| 510k Number | K162636 |
| Device Name: | Marco Ultra M3, Marco Ultra M4 |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | TAKAGI SEIKO CO.LTD. 330-2 IWAHUNE, NAKANO-SHI, NAGANO-KEN Nakano, JP 383-8585 |
| Contact | Hagiwara Toru |
| Correspondent | Hagiwara Toru TAKAGI SEIKO CO.LTD. 330-2 IWAHUNE, NAKANO-SHI, NAGANO-KEN Nakano, 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 | 2016-09-21 |
| Decision Date | 2017-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06909071678474 | K162636 | 000 |
| 06909071678467 | K162636 | 000 |
| 04560323648472 | K162636 | 000 |
| 04560323648465 | K162636 | 000 |
| 04560323641183 | K162636 | 000 |
| 04560323641176 | K162636 | 000 |