The following data is part of a premarket notification filed by Simondr, Inc. with the FDA for Simondr Drp.
| Device ID | K093790 |
| 510k Number | K093790 |
| Device Name: | SIMONDR DRP |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | SIMONDR, INC. 3515 MARMENCO COURT Baltimore, MD 21230 |
| Contact | Valerie Lohr |
| Correspondent | Valerie Lohr SIMONDR, INC. 3515 MARMENCO COURT Baltimore, MD 21230 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-10 |
| Decision Date | 2010-04-05 |
| Summary: | summary |