510(k) K131590

INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE by Philips Medical Systems — Product Code FPD

K131590 is an FDA 510(k) premarket notification submitted by Philips Medical Systems for the device "INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE". The FDA issued a decision of Substantially Equivalent on October 23, 2013. The device falls under product code FPD (Tube, Feeding), a Class II device regulated under 21 CFR 876.5980. Philips Medical Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2013
Date Received
May 31, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Feeding
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type