The following data is part of a premarket notification filed by Konica Minolta Medical & Graphic, Inc. with the FDA for Aerodr System.
| Device ID | K102349 |
| 510k Number | K102349 |
| Device Name: | AERODR SYSTEM |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-19 |
| Decision Date | 2010-11-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560141941434 | K102349 | 000 |
| 04560141934719 | K102349 | 000 |
| 04560141934399 | K102349 | 000 |
| 04560141933613 | K102349 | 000 |