510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K123195Substantially Equivalent

Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and Accessories

GE Healthcare Finland Oy, Helsinki, FI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123195 is the FDA 510(k) clearance record for CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES, a class II device, cleared for GE Healthcare Finland Oy on under FDA product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase). FDA records list 30 510(k) clearances for GE Healthcare Finland Oy, from to . As of , FDA records show 4 recalls naming K123195.

Clearance record

Decision date
Received
(140 days to decision)
Product code
CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Regulation
21 CFR 868.1720
Device class
Class II
Review panel
Anesthesiology
Applicant
GE Healthcare Finland Oy Kuortaneenkatu 2, Helsinki, FI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CCL

Trailing 12 months
1 clearance under product code CCL in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CCL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260