MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM


Device Classification Name

ventilatory effort recorder

510(k) Number K022506
Device Name MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM
Original Applicant
WIDEMED LTD
omer industrial park, bldg 8c
pob 3002
omer, 

IL

84965

Original Contact david solomon
Regulation Number 868.2375
Classification Product Code
MNR  
Date Received 07/30/2002
Decision Date 05/15/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No