The following data is part of a premarket notification filed by Codonics, Inc. with the FDA for Np-2600 Series Hardcopy Printers.
| Device ID | K042232 |
| 510k Number | K042232 |
| Device Name: | NP-2600 SERIES HARDCOPY PRINTERS |
| Classification | Camera, Multi Format, Radiological |
| Applicant | CODONICS, INC. 17991 ENGLEWOOD DR. Middleburg Heights, OH 44130 |
| Contact | Alan Desantis |
| Correspondent | Alan Desantis CODONICS, INC. 17991 ENGLEWOOD DR. Middleburg Heights, OH 44130 |
| Product Code | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-17 |
| Decision Date | 2004-10-05 |
| Summary: | summary |