The following data is part of a premarket notification filed by Konica Minolta Medical & Graphic, Inc. with the FDA for Aerodr System With P-21.
| Device ID | K113248 |
| 510k Number | K113248 |
| Device Name: | AERODR SYSTEM WITH P-21 |
| Classification | System, X-ray, Stationary |
| Applicant | KONICA MINOLTA MEDICAL & GRAPHIC, INC. 140 EAST 45TH ST., 25TH FLOOR TWO GRAND CENTRAL TOWER New York, NY 10017 |
| Contact | Russell Munves |
| Correspondent | Russell Munves KONICA MINOLTA MEDICAL & GRAPHIC, INC. 140 EAST 45TH ST., 25TH FLOOR TWO GRAND CENTRAL TOWER New York, NY 10017 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-03 |
| Decision Date | 2012-01-17 |
| Summary: | summary |