510(k) K862171

MP-500 ELECTRONIC NEBULIZER by The Timeter Group — Product Code KFZ

K862171 is an FDA 510(k) premarket notification submitted by The Timeter Group for the device "MP-500 ELECTRONIC NEBULIZER". The FDA issued a decision of Substantially Equivalent on July 14, 1986. The device falls under product code KFZ (Humidifier, Non-Direct Patient Interface (Home-Use)), a Class I device regulated under 21 CFR 868.5460. The Timeter Group has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1986
Date Received
June 9, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Humidifier, Non-Direct Patient Interface (Home-Use)
Device Class
Class I
Regulation Number
868.5460
Review Panel
AN
Submission Type