The following data is part of a premarket notification filed by Erka Kallmeyer Medizintechnik Gmbh with the FDA for Erka. Perfect-aneroid.
| Device ID | K103637 |
| 510k Number | K103637 |
| Device Name: | ERKA. PERFECT-ANEROID |
| Classification | Blood Pressure Cuff |
| Applicant | ERKA KALLMEYER MEDIZINTECHNIK GMBH IM FARCHET 15 Bad Toelz, Bavaria, DE 83646 |
| Contact | Jan Weiss |
| Correspondent | Norbert Stuiber TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-12-13 |
| Decision Date | 2011-06-08 |
| Summary: | summary |