510(k) K895115

FRANK INHALER THERMAL S by Buttner-Frank GmbH — Product Code CCQ

K895115 is an FDA 510(k) premarket notification submitted by Buttner-Frank GmbH for the device "FRANK INHALER THERMAL S". The FDA issued a decision of Substantially Equivalent on May 18, 1990. The device falls under product code CCQ (Nebulizer, Medicinal, Non-Ventilatory (Atomizer)), a Class I device regulated under 21 CFR 868.5640. Buttner-Frank GmbH has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1990
Date Received
August 15, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Device Class
Class I
Regulation Number
868.5640
Review Panel
AN
Submission Type