The following data is part of a premarket notification filed by Hoana Medical, Inc. with the FDA for Lifebed Patient Vigilance System.
| Device ID | K082366 |
| 510k Number | K082366 |
| Device Name: | LIFEBED PATIENT VIGILANCE SYSTEM |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | HOANA MEDICAL, INC. 828 FORT STREET MALL SUITE 620 Honolulu, HI 96825 |
| Contact | Nancy Gertlar |
| Correspondent | Nancy Gertlar HOANA MEDICAL, INC. 828 FORT STREET MALL SUITE 620 Honolulu, HI 96825 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-18 |
| Decision Date | 2008-09-26 |
| Summary: | summary |