The following data is part of a premarket notification filed by Codonics, Inc. with the FDA for Codonics Medical Printer (np-1600m,np1600md).
| Device ID | K962364 |
| 510k Number | K962364 |
| Device Name: | CODONICS MEDICAL PRINTER (NP-1600M,NP1600MD) |
| Classification | Camera, Multi Format, Radiological |
| Applicant | CODONICS, INC. 17991 ENGLEWOOD DR. Middleburg Heights, OH 44130 |
| Contact | Peter Botten |
| Correspondent | Peter Botten 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 | 1996-06-19 |
| Decision Date | 1996-11-08 |
| Summary: | summary |