510(k) K103059

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

February 24, 2011

Date Received

October 15, 2010

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist

Device Class

Class II

Regulation Number

892.1570

Review Panel

HO

Submission Type

To provide high level disinfection of ultrasound transducers. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).