SLEEPSTRIP DISPOSABLE APNEA SCREENER


the company

Device Classification Name

ventilatory effort recorder

510(k) Number K002135
Device Name SLEEPSTRIP DISPOSABLE APNEA SCREENER
Original Applicant
INFLUENT LTD.
555 thirteenth street, n.w.
washington, 
DC 

Original Contact jonathan s kahan
Regulation Number 868.2375
Classification Product Code
MNR  
Date Received 07/14/2000
Decision Date 12/06/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

Type Traditional
Reviewed by Third Party No

Combination Product

No