PATIENT ISOLATION UNIT, MODEL G019-1000— 510(k) K080117
Substantially EquivalentGentex Corporation
FDA 510(k) clearance K080117 for PATIENT ISOLATION UNIT, MODEL G019-1000, Substantially Equivalent on 2009-01-30. Applicant: Gentex Corporation.
Clearance details
- Applicant
- Gentex Corporation
- Product code
- Code LGM
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rancho Cucamonga, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.