SMARTMONITOR 2, MODEL 4000


Device Classification Name

monitor, apnea, facility use

510(k) Number K011597
Device Name SMARTMONITOR 2, MODEL 4000
Original Applicant
RESPIRONICS GEORGIA, INC.
175 chastain meadows court
kennesaw, 
GA 
30144

Original Contact betsy cortelloni
Regulation Number 868.2377
Classification Product Code
FLS  
Date Received 05/24/2001
Decision Date 01/11/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls
Category: Uncategorized