LIFEBED PATIENT VIGILANCE SYSTEM— 510(k) K082366

Substantially Equivalent

Hoana Medical, Inc.

FDA 510(k) clearance K082366 for LIFEBED PATIENT VIGILANCE SYSTEM, Substantially Equivalent on 2008-09-26. Applicant: Hoana Medical, Inc..

Clearance details

Applicant: Hoana Medical, Inc.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 2008-08-18
Decision date: 2008-09-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Honolulu, HI, US

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Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.