The following data is part of a premarket notification filed by Industrielle Entwicklung Medizintechnik Und Vertri with the FDA for Watch Style Wrist Digital Blood Pressure Monitor, Model: Klock.
| Device ID | K991545 |
| 510k Number | K991545 |
| Device Name: | WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL: KLOCK |
| Classification | Blood Pressure Cuff |
| Applicant | INDUSTRIELLE ENTWICKLUNG MEDIZINTECHNIK UND VERTRI 11641 RED HIBISCUS DR. Bonita Springs, FL 34135 |
| Contact | Guenter Ginsberg |
| Correspondent | Guenter Ginsberg INDUSTRIELLE ENTWICKLUNG MEDIZINTECHNIK UND VERTRI 11641 RED HIBISCUS DR. Bonita Springs, FL 34135 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-03 |
| Decision Date | 2000-01-19 |