510(k) K051313

BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER by Salter Labs — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2005
Date Received
May 19, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilatory Effort Recorder
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type