EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & MMHG)


Device Classification Name

analyzer, gas, carbon-dioxide, gaseous-phase

510(k) Number K072813
Device Name EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & MMHG)
Applicant
PHASEIN AB
4213 winnequah dr.
madison, 
WI 
53716

Applicant Contact david weissburg
Correspondent
PHASEIN AB
4213 winnequah dr.
madison, 
WI 
53716

Correspodent Contact david weissburg
Regulation Number 868.1400
Classification Product Code
CCK  
Date Received 10/01/2007
Decision Date 12/28/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No