The following data is part of a premarket notification filed by Konica Minolta Medical & Graphic, Inc. with the FDA for Laser Imager Drypro Model 873.
| Device ID | K081637 |
| 510k Number | K081637 |
| Device Name: | LASER IMAGER DRYPRO MODEL 873 |
| Classification | Camera, Multi Format, Radiological |
| 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 | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-11 |
| Decision Date | 2008-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560141923126 | K081637 | 000 |
| 04560141923119 | K081637 | 000 |
| 04560141950474 | K081637 | 000 |