The following data is part of a premarket notification filed by Health & Life Co., Ltd. with the FDA for Hl888 Af.
Device ID | K032913 |
510k Number | K032913 |
Device Name: | HL888 AF |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | HEALTH & LIFE CO., LTD. 9F, NO.186, JIAN YI ROAD Chung Ho City, Taipei, TW 235 |
Contact | Paul Hung |
Correspondent | Paul Hung HEALTH & LIFE CO., LTD. 9F, NO.186, JIAN YI ROAD Chung Ho City, Taipei, TW 235 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-02 |
Decision Date | 2003-10-02 |