The following data is part of a premarket notification filed by Konica Minolta Medical & Graphic, Inc. with the FDA for Aerodr System With P-31.
| Device ID | K130936 |
| 510k Number | K130936 |
| Device Name: | AERODR SYSTEM WITH P-31 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | KONICA MINOLTA MEDICAL & GRAPHIC, INC. 140 EAST 45TH ST., 25TH FLOOR TWO GRAND CENTRAL TOWER New York, NY 10017 |
| Contact | Russel Munves |
| Correspondent | Russel Munves KONICA MINOLTA MEDICAL & GRAPHIC, INC. 140 EAST 45TH ST., 25TH FLOOR TWO GRAND CENTRAL TOWER New York, NY 10017 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-04 |
| Decision Date | 2013-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560141940628 | K130936 | 000 |
| 04560141938649 | K130936 | 000 |