HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS


Device Classification Name

chamber, hyperbaric

510(k) Number K081506
Device Name HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS
Applicant
HYPERBARIC AMERICA, LLC
1811 copper ridge dr.
san antonio, 
TX 
78259

Applicant Contact tom workman
Correspondent
HYPERBARIC AMERICA, LLC
1811 copper ridge dr.
san antonio, 
TX 
78259

Correspodent Contact tom workman
Regulation Number 868.5470
Classification Product Code
CBF  
Date Received 05/29/2008
Decision Date 07/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No