The following data is part of a premarket notification filed by Getemed Medizin- Und Informationstechnik Ag with the FDA for Seer 1000.
| Device ID | K130785 |
| 510k Number | K130785 |
| Device Name: | SEER 1000 |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG ODERSTRASSE 77 Teltow, DE 14513 |
| Contact | Bert Schadow |
| Correspondent | Bert Schadow GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG ODERSTRASSE 77 Teltow, DE 14513 |
| Product Code | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-21 |
| Decision Date | 2013-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250903201202 | K130785 | 000 |
| 04250903201677 | K130785 | 000 |
| 04250903201660 | K130785 | 000 |
| 04250903201653 | K130785 | 000 |
| 04250903201646 | K130785 | 000 |
| 04250903201639 | K130785 | 000 |
| 04250903201622 | K130785 | 000 |
| 04250903201615 | K130785 | 000 |
| 04250903201608 | K130785 | 000 |
| 04250903201592 | K130785 | 000 |
| 04250903201585 | K130785 | 000 |
| 00840682116886 | K130785 | 000 |
| 00840682116879 | K130785 | 000 |
| 04250903201684 | K130785 | 000 |
| 04250903201691 | K130785 | 000 |
| 04250903200755 | K130785 | 000 |
| 04250903201196 | K130785 | 000 |
| 04250903200861 | K130785 | 000 |
| 04250903200854 | K130785 | 000 |
| 04250903200847 | K130785 | 000 |
| 04250903200830 | K130785 | 000 |
| 04250903200823 | K130785 | 000 |
| 04250903200816 | K130785 | 000 |
| 04250903200809 | K130785 | 000 |
| 04250903200793 | K130785 | 000 |
| 04250903200786 | K130785 | 000 |
| 04250903200779 | K130785 | 000 |
| 04250903200762 | K130785 | 000 |
| 00840682108232 | K130785 | 000 |