FDA 510(k)

NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002

K-Number: K070255 · 2007-06-13

Decision Date2007-06-13

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002 is the device name listed in this FDA 510(k) record. The listed applicant is Nova Biomedical Corp.. It received FDA 510(k) clearance on 2007-06-13 under 510(k) number K070255. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002?

NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002 is a medical device that received FDA 510(k) clearance on 2007-06-13. The listed applicant is Nova Biomedical Corp.. The 510(k) number is K070255.

When did NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002 receive FDA 510(k) clearance?

NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002 received FDA 510(k) clearance on 2007-06-13, under 510(k) number K070255.

Who is the listed applicant for NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002?

The FDA 510(k) record lists Nova Biomedical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002?

The FDA product code for NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002 is NBW. This falls under the OB/GYN category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Nova Biomedical Corp. as applicant

K100602NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS K101633NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH K091547NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS K070960NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM K070068NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS K063821NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

View all 89 devices →

Related Devices (Code: NBW)

K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care K262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc.K250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring SystemACON Laboratories, Inc.K243060TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd.K240637RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation K240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemSejoy Biomedical Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.