EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER

Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

MEDICA CORP.

The following data is part of a premarket notification filed by Medica Corp. with the FDA for Easystat Ph, Pco2, Po2, Htc, Na, K, Cl Analyzer.

Pre-market Notification Details

• Device ID: K063376
• 510k Number: K063376
• Device Name: EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER
• Classification: Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
• Applicant: MEDICA CORP. 5 OAK PARK DRIVE Bedford, MA 01730
• Contact: Photios Makris
• Correspondent: Photios Makris; MEDICA CORP. 5 OAK PARK DRIVE Bedford, MA 01730
• Product Code: CHL
• Subsequent Product Code: CEM
• Subsequent Product Code: CGZ
• Subsequent Product Code: GKF
• Subsequent Product Code: JFP
• Subsequent Product Code: JGS
• CFR Regulation Number: 862.1120 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-11-08
• Decision Date: 2007-06-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00386100003630	K063376	000
00386100002619	K063376	000
00630414566276	K063376	000