STAT PROFILE PHOX PLUS L ANALYZER

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

NOVA BIOMEDICAL CORP.

The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Stat Profile Phox Plus L Analyzer.

Pre-market Notification Details

• Device ID: K023567
• 510k Number: K023567
• Device Name: STAT PROFILE PHOX PLUS L ANALYZER
• Classification: Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
• Applicant: NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141
• Contact: Paul W Macdonald
• Correspondent: Paul W Macdonald; NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141
• Product Code: CHL
• Subsequent Product Code: CEM
• Subsequent Product Code: CGZ
• Subsequent Product Code: GJS
• Subsequent Product Code: GKR
• Subsequent Product Code: JFP
• Subsequent Product Code: JIX
• Subsequent Product Code: JKS
• Subsequent Product Code: JPI
• Subsequent Product Code: JPK
• Subsequent Product Code: KHP
• CFR Regulation Number: 862.1120 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-10-23
• Decision Date: 2002-12-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00385480341172	K023567	000
00385480338714	K023567	000
00385480336260	K023567	000
10385480336236	K023567	000