The following data is part of a premarket notification filed by Gonotec Gesellschaft Fuer Mess-und Regeltechnik Mb with the FDA for Gonotec Calibration Solution 300 Mosmol/kg For Osmometer.
| Device ID | K032608 |
| 510k Number | K032608 |
| Device Name: | GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER |
| Classification | Calibrator, Primary |
| Applicant | GONOTEC GESELLSCHAFT FUER MESS-UND REGELTECHNIK MB SCHOENHAUSER STRASSE 73C Berlin, DE 13158 |
| Contact | Thomas Bock |
| Correspondent | Thomas Bock GONOTEC GESELLSCHAFT FUER MESS-UND REGELTECHNIK MB SCHOENHAUSER STRASSE 73C Berlin, DE 13158 |
| Product Code | JIS |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-25 |
| Decision Date | 2003-10-21 |
| Summary: | summary |