The following data is part of a premarket notification filed by Nical Spa with the FDA for Ndr+/diva-d.
| Device ID | K053029 |
| 510k Number | K053029 |
| Device Name: | NDR+/DIVA-D |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | NICAL SPA 71 ROSE STREET Hasting On Hudson, NY 10706 |
| Contact | Gerald Silverman |
| Correspondent | Gerald Silverman NICAL SPA 71 ROSE STREET Hasting On Hudson, NY 10706 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-27 |
| Decision Date | 2006-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056600520051 | K053029 | 000 |
| 08056600520044 | K053029 | 000 |