The following data is part of a premarket notification filed by Hoana Medical, Inc. with the FDA for Lg1 Intelligent Medical Vigilance System.
| Device ID | K052446 |
| 510k Number | K052446 |
| Device Name: | LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | HOANA MEDICAL, INC. 1001 BISHOP STREET, STE 2828 AMERICAN SAVINGS BANK TOWER Honolulu, HI 96813 |
| Contact | Matthew S Glei |
| Correspondent | Matthew S Glei HOANA MEDICAL, INC. 1001 BISHOP STREET, STE 2828 AMERICAN SAVINGS BANK TOWER Honolulu, HI 96813 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-07 |
| Decision Date | 2006-02-02 |
| Summary: | summary |