The following data is part of a premarket notification filed by Eresearchtechnology Gmbh with the FDA for Masterscope, Masterscope Ct, Masterscope Ecg, Masterscope Wssu.
| Device ID | K202754 |
| 510k Number | K202754 |
| Device Name: | MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | eResearchTechnology GmbH Sieboldstrasse 3 Estenfeld, DE 97230 |
| Contact | Margit Kohlen |
| Correspondent | Margit Kohlen eResearchTechnology GmbH Sieboldstrasse 3 Estenfeld, DE 97230 |
| Product Code | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-21 |
| Decision Date | 2021-01-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04057155000641 | K202754 | 000 |
| 04057155000634 | K202754 | 000 |
| 04057155000566 | K202754 | 000 |