CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

GE Healthcare Finland Oy

The following data is part of a premarket notification filed by Ge Healthcare Finland Oy with the FDA for Carescape Respiratory Modules, E-sco, E-scov, E-scovx, E-scaio.

Pre-market Notification Details

• Device ID: K183394
• 510k Number: K183394
• Device Name: CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO
• Classification: Analyzer, Gas, Carbon-dioxide, Gaseous-phase
• Applicant: GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki, FI Fi-00510
• Contact: Joel Kent
• Correspondent: Anna Pehrsson; GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki, FI Fi-00510
• Product Code: CCK
• Subsequent Product Code: BZK
• Subsequent Product Code: BZL
• Subsequent Product Code: CAP
• Subsequent Product Code: CBQ
• Subsequent Product Code: CBR
• Subsequent Product Code: CBS
• Subsequent Product Code: CCL
• Subsequent Product Code: NHO
• Subsequent Product Code: NHP
• Subsequent Product Code: NHQ
• CFR Regulation Number: 868.1400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-12-07
• Decision Date: 2019-05-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840682138161	K183394	000
00840682138147	K183394	000