Atlas FDA

LZF

7 FDA 510(k) clearances · Product code

320 daysmedian time to decision
627 days90th percentile
7clearances measured

FDA profile

Official device name
Pump, Infusion, Analytical Sampling
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5725
Medical specialty
General Hospital
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RecordFirmDate
OptiScanner® 5000 Glucose Monitoring System (K192785)Optiscan Biomedical Corporation2020-02-05
OptiScanner 5000 Glucose Monitoring System (K162042)Optiscan Biomedical Corp.2017-10-16
RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM (K011238)Metracor Technologies, Inc.2002-01-08
PUMP/BLOOD CHEMISTRY MONITOR (K951739)Via Medical Corp.1996-02-28
VIA 1-01 INFUSION PUMP/BLOOD CHEM. SYST. -- MOD. (K922997)Via Medical Corp.1994-01-11
VIA 1-01 INFUSION PUMP BLOOD CHEMISTRY SYSTEM (K920438)Via Medical Corp.1993-10-22
INFUSION PUMP (K882830)Pemlab Corp.1988-12-30

Track LZF automatically

Every clearance here is in the API, with alerts when new ones post.