BAYER RAPIDPOINT 400 SYSTEM

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

BAYER CORP.

The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Bayer Rapidpoint 400 System.

Pre-market Notification Details

• Device ID: K002738
• 510k Number: K002738
• Device Name: BAYER RAPIDPOINT 400 SYSTEM
• Classification: Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
• Applicant: BAYER CORP. 63 NORTH ST. Medfield, MA 02052 -1688
• Contact: William J Pignato
• Correspondent: William J Pignato; BAYER CORP. 63 NORTH ST. Medfield, MA 02052 -1688
• Product Code: CHL
• Subsequent Product Code: CEM
• Subsequent Product Code: CGA
• 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: 2000-09-01
• Decision Date: 2000-12-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00630414515250	K002738	000
00630414482163	K002738	000
00630414469225	K002738	000
00630414465883	K002738	000
00630414444581	K002738	000
00630414443492	K002738	000
00630414443485	K002738	000
00630414016627	K002738	000