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510(k) K051279

CALDYNE, INC. EXHALOMETER EX100, MODEL EX100 by Caldyne, Inc. — Product Code BZK

K051279 is an FDA 510(k) premarket notification submitted by Caldyne, Inc. for the device "CALDYNE, INC. EXHALOMETER EX100, MODEL EX100". The FDA issued a decision of Substantially Equivalent on September 7, 2005. The device falls under product code BZK (Spirometer, Monitoring (W/Wo Alarm)), a Class II device regulated under 21 CFR 868.1850.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2005
Date Received
May 17, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Monitoring (W/Wo Alarm)
Device Class
Class II
Regulation Number
868.1850
Review Panel
AN
Submission Type

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FDA data resources