The following data is part of a premarket notification filed by Northh Medical Gmbh with the FDA for Smart-sync.
| Device ID | K212271 |
| 510k Number | K212271 |
| Device Name: | Smart-sync |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | northh Medical GmbH Roentgenstrasse 24 Hamburg, DE 22335 |
| Contact | Kai-kristoph Fehrs |
| Correspondent | Kai-kristoph Fehrs northh Medical GmbH Roentgenstrasse 24 Hamburg, DE 22335 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-20 |
| Decision Date | 2022-02-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260675390011 | K212271 | 000 |
| 04260675390028 | K212271 | 000 |