FDA 510(k)

GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS

K-Number: K121433 · 2013-02-14

Decision Date2013-02-14

Product CodeLFR

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Hmd Biomedical, Inc.. It received FDA 510(k) clearance on 2013-02-14 under 510(k) number K121433. The device is classified under product code LFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS?

GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS is a medical device that received FDA 510(k) clearance on 2013-02-14. The listed applicant is Hmd Biomedical, Inc.. The 510(k) number is K121433.

When did GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS receive FDA 510(k) clearance?

GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS received FDA 510(k) clearance on 2013-02-14, under 510(k) number K121433.

Who is the listed applicant for GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS?

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

What is the FDA product code for GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS?

The FDA product code for GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS is LFR.

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Other records listing Hmd Biomedical, Inc. as applicant

K212248GlucoLeader Enhance 2 Blood Glucose Monitoring System K182428GlucoLeader Enhance Blood Glucose Monitoring System K113314PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM K120064TEST, BLOOD GLUCOSE SYSTEM K113307GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM K032985GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM

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Related Devices (Code: LFR)

K131366ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEMRoche Diagnostics Operations, Inc.K122688NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITORNova Biomedical Corporation K122435NOVA ONE BLOOD GLUCOSE MONITORNova Biomedical Corporation K113314PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEMHmd Biomedical, Inc.K121224GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEMTaidoc Technology Corporation K113307GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEMHmd Biomedical, Inc.

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.