The following data is part of a premarket notification filed by Heine Optotechnik Gmbh & Co. Kg. with the FDA for Heine Gamma G7; Heine Gamma G5, Heine Gamma Gp, Heine Gamma Gst, Heine Gamma Xxl Lf Model M-000.09.23x, M-000.09.24x, M-.
| Device ID | K101892 |
| 510k Number | K101892 |
| Device Name: | HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M- |
| Classification | Blood Pressure Cuff |
| Applicant | HEINE OPTOTECHNIK GMBH & CO. KG. BEIM STROHHAUSE 27 Hamburg, DE 20097 |
| Contact | Thomas Weber |
| Correspondent | Thomas Weber HEINE OPTOTECHNIK GMBH & CO. KG. BEIM STROHHAUSE 27 Hamburg, DE 20097 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-07 |
| Decision Date | 2010-08-27 |
| Summary: | summary |