SNORE SAT RECORDER, MODEL SS41


the company

Device Classification Name

ventilatory effort recorder

510(k) Number K002159
Device Name SNORE SAT RECORDER, MODEL SS41
Original Applicant
SAGATECH ELECTRONICS, INC.
3413 8th st., s.e.
calgary, alberta, 

CA

t2g3a4

Original Contact heather platt-melax
Regulation Number 868.2375
Classification Product Code
MNR  
Date Received 07/17/2000
Decision Date 06/28/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls