HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861


Device Classification Name

oximeter, reprocessed

510(k) Number K080424
Device Name HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861
Applicant
HYGIA HEALTH SERVICES, INC.
434 industrial ln.
birmingham, 
AL 
35211

Applicant Contact jerome james
Correspondent
HYGIA HEALTH SERVICES, INC.
434 industrial ln.
birmingham, 
AL 
35211

Correspodent Contact jerome james
Regulation Number 870.2700
Classification Product Code
NLF  
Date Received 02/15/2008
Decision Date 05/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No