510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111905Substantially Equivalent

Intellivue Guardian Software Model 866009, Intellivue Cl Sp02 Pod Model 865215, Intellivue Cl Nbp Pod Model 865216

Philips Medizinsysteme Boeblingen GmbH, Cardiac an, Boeblingen, Baden-Wuerttemberg, DE / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111905 is the FDA 510(k) clearance record for INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, a class II device, cleared for Philips Medizinsysteme Boeblingen GmbH, Cardiac AN on under FDA product code DXJ (Display, Cathode-Ray Tube, Medical). FDA records list 25 510(k) clearances for Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, from to . As of , FDA records show no recalls naming K111905.

Clearance record

Decision date
Received
(91 days to decision)
Product code
DXJ Display, Cathode-Ray Tube, Medical
Regulation
21 CFR 870.2450
Device class
Class II
Review panel
Cardiovascular
Applicant
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN Hewlett-Packard St. 2, Boeblingen, Baden-Wuerttemberg, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXJ

Trailing 12 months

FDA records hold no clearances under product code DXJ in the trailing twelve months.

FDA records show no clearances under product code DXJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DXJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260