The following data is part of a premarket notification filed by Mse Medizintechnik Gmbh & Co. Kg with the FDA for Polyscan Digital Scanner.
| Device ID | K944684 |
| 510k Number | K944684 |
| Device Name: | POLYSCAN DIGITAL SCANNER |
| Classification | Scanner, Rectilinear, Nuclear |
| Applicant | MSE MEDIZINTECHNIK GMBH & CO. KG CARL ZEISS STRASSES 18, D-6074 Rodemark, DE D-6074 |
| Contact | Eduard J Botz |
| Correspondent | Eduard J Botz MSE MEDIZINTECHNIK GMBH & CO. KG CARL ZEISS STRASSES 18, D-6074 Rodemark, DE D-6074 |
| Product Code | IYW |
| CFR Regulation Number | 892.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-22 |
| Decision Date | 1995-05-15 |