The following data is part of a premarket notification filed by Yamasu Co. Ltd. with the FDA for Home Blood Pressure Kit, Aneroid.
| Device ID | K884420 |
| 510k Number | K884420 |
| Device Name: | HOME BLOOD PRESSURE KIT, ANEROID |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | YAMASU CO. LTD. 100 NUKUI KAMIKAWA MURA KODAMA GUN Saitama Pref., JP |
| Contact | Watanabe |
| Correspondent | Watanabe YAMASU CO. LTD. 100 NUKUI KAMIKAWA MURA KODAMA GUN Saitama Pref., JP |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-20 |
| Decision Date | 1989-08-25 |