The following data is part of a premarket notification filed by Edda Technology with the FDA for Iqqa Guide.
| Device ID | K151414 |
| 510k Number | K151414 |
| Device Name: | IQQA Guide |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | EDDA TECHNOLOGY 5 INDEPENDENCE WAY Princeton, NJ 08540 |
| Contact | Xiaolan Zeng |
| Correspondent | Daniel Kamm EDDA TECHNOLOGY 5 INDEPENDENCE WAY Princeton, NJ 08540 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-27 |
| Decision Date | 2015-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868466000237 | K151414 | 000 |