The following data is part of a premarket notification filed by Solutions For Tomorrow Ab with the FDA for !m1.
| Device ID | K170607 |
| 510k Number | K170607 |
| Device Name: | !M1 |
| Classification | System, X-ray, Mobile |
| Applicant | Solutions For Tomorrow AB Saxagardsv. 4 Vackelsang, SE 36251 |
| Contact | Martin Yngvesson |
| Correspondent | Martin Yngvesson Solutions For Tomorrow AB Saxagardsv. 4 Vackelsang, SE 36251 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-01 |
| Decision Date | 2017-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350011170012 | K170607 | 000 |