EMBLA N7000


Device Classification Name

ventilatory effort recorder

510(k) Number K024322
Device Name EMBLA N7000
Original Applicant
MEDCARE FLAGA
46 loch haven ln.
battle creek, 
MI 
49015

Original Contact kumar kulkarni
Regulation Number 868.2375
Classification Product Code
MNR  
Date Received 12/26/2002
Decision Date 10/27/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No