IQ NASAL MASK, MODEL 50160 REV. D


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K021534
Device Name IQ NASAL MASK, MODEL 50160 REV. D
Original Applicant
SLEEPNET CORPORATION
1050 perimeter rd.,
lockheed air center
manchester, 
NH 
03103

Original Contact paul r chiesa
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 05/10/2002
Decision Date 07/02/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No