510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K151366Substantially Equivalent

Philips CS770 IntelliSpace Critical Care and Anesthesia

Philips North America LLC, Andover MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K151366 is the FDA 510(k) clearance record for Philips CS770 IntelliSpace Critical Care and Anesthesia, a class II device, cleared for Philips Medical Systems on under FDA product code DXJ (Display, Cathode-Ray Tube, Medical). FDA records list 680 510(k) clearances for Philips North America LLC, from to . As of , FDA records show no recalls naming K151366.

Clearance record

Decision date
Received
(162 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 Medical Systems 3000 Minuteman Rd., Andover MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXJ

Trailing 12 months
1 clearance under product code DXJ in the twelve months to October 2026, September 2026 the highest month at 1.
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 20261
October 20260