SLEEPMINDER BREATHING FREQUENCY INDICATOR


Device Classification Name

monitor, breathing frequency

510(k) Number K103631
Device Name SLEEPMINDER BREATHING FREQUENCY INDICATOR
Applicant
BIANCAMED LIMITED
novaucd, belfield innovation p
university college dublin
belfield, dublin, 

IE

4

Applicant Contact paul phillips
Correspondent
BIANCAMED LIMITED
novaucd, belfield innovation p
university college dublin
belfield, dublin, 

IE

4

Correspodent Contact paul phillips
Regulation Number 868.2375
Classification Product Code
BZQ  
Date Received 12/13/2010
Decision Date 07/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Clinical Trials NCT01319396
Reviewed by Third Party No

Combination Product

No