510(k) K072418

OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER by Respironics New Jersey, Inc. — Product Code CAF

K072418 is an FDA 510(k) premarket notification submitted by Respironics New Jersey, Inc. for the device "OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER". The FDA issued a decision of Substantially Equivalent on September 12, 2007. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Respironics New Jersey, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2007
Date Received
August 28, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type