The following data is part of a premarket notification filed by Cardinal Health Germany 234 Gmbh with the FDA for Masterscope, Masterscope Ecg, Masterscope Ct.
| Device ID | K082539 |
| 510k Number | K082539 |
| Device Name: | MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | CARDINAL HEALTH GERMANY 234 GMBH LEIBNIZSTRASSE 7 Hoechberg, Bavaria, DE 97204 |
| Contact | Thomas Rust |
| Correspondent | Thomas Rust CARDINAL HEALTH GERMANY 234 GMBH LEIBNIZSTRASSE 7 Hoechberg, Bavaria, DE 97204 |
| Product Code | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-02 |
| Decision Date | 2008-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04057155000061 | K082539 | 000 |
| 04057155000054 | K082539 | 000 |
| 04057155000030 | K082539 | 000 |
| 04057155000023 | K082539 | 000 |
| 04057155000016 | K082539 | 000 |
| 04057155000627 | K082539 | 000 |
| 04057155000610 | K082539 | 000 |