510(k) K200722

PCA-C1 series Patient Cable by QT Medical, Inc. — Product Code DSA

K200722 is an FDA 510(k) premarket notification submitted by QT Medical, Inc. for the device "PCA-C1 series Patient Cable". The FDA issued a decision of Substantially Equivalent on June 3, 2021. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900. QT Medical, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2021
Date Received
March 19, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Device Class
Class II
Regulation Number
870.2900
Review Panel
CV
Submission Type