510(k) K061705

CADWELL EASYNET NASAL PRESSURE MODULE by Cadwell Laboratories, Inc. — Product Code MNR

K061705 is an FDA 510(k) premarket notification submitted by Cadwell Laboratories, Inc. for the device "CADWELL EASYNET NASAL PRESSURE MODULE". The FDA issued a decision of Substantially Equivalent on November 21, 2006. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Cadwell Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2006
Date Received
June 16, 2006
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