PATIENT ISOLATION UNIT, MODEL G019-1000


Device Classification Name

chamber, patient isolation

510(k) Number K080117
Device Name PATIENT ISOLATION UNIT, MODEL G019-1000
Applicant
GENTEX CORPORATION
11525 sixth st.
rancho cucamonga, 
CA 
91730

Applicant Contact barry shope
Correspondent
GENTEX CORPORATION
11525 sixth st.
rancho cucamonga, 
CA 
91730

Correspodent Contact barry shope
Regulation Number 880.5450
Classification Product Code
LGM  
Date Received 01/17/2008
Decision Date 01/30/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No