STAT PROFILE PHOX PLUS C 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 C Analyzer.

Pre-market Notification Details

• Device ID: K021713
• 510k Number: K021713
• Device Name: STAT PROFILE PHOX PLUS C 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: CGA
• Subsequent Product Code: CGZ
• Subsequent Product Code: GKR
• Subsequent Product Code: JEP
• Subsequent Product Code: JGS
• Subsequent Product Code: JIX
• Subsequent Product Code: JKS
• Subsequent Product Code: JPI
• Subsequent Product Code: JPK
• CFR Regulation Number: 862.1120 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-05-23
• Decision Date: 2002-07-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00385480418898	K021713	000
00385480418881	K021713	000
00385480418874	K021713	000
00385480373432	K021713	000
00385480239370	K021713	000
00385480219266	K021713	000