Name: Predicase
Price: 199 USD

K-number	K954391
Device name	MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER
Applicant	Bio-Tek Instruments, Inc.
Product code	DRL
Device class	Class II
Decision date	Nov 17, 1995
Decision	Substantially Equivalent
Regulation	870.5325

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Source

View the full FDA submission: accessdata.fda.gov

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MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER

Everything you need for a 510(k) submission. Nothing you don't.