510(k) K240784

Temperature Sensor Probe (ABL-18TP20) by Varian Medical Systems, Inc. — Product Code NEY

K240784 is an FDA 510(k) premarket notification submitted by Varian Medical Systems, Inc. for the device "Temperature Sensor Probe (ABL-18TP20)". The FDA issued a decision of Substantially Equivalent on May 29, 2024. The device falls under product code NEY (System, Ablation, Microwave And Accessories), a Class II device regulated under 21 CFR 878.4400. Varian Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2024
Date Received
March 21, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Ablation, Microwave And Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type