TWLIGHT, MODEL ISP 9600


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K022642
Device Name TWLIGHT, MODEL ISP 9600
Original Applicant
INVACARE CORP.
one invacare way
elyria, 
OH 
44036 -2125

Original Contact rae ann farrow
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 08/08/2002
Decision Date 02/11/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No