Name: Predicase
Price: 199 USD

K-number	K014157
Device name	HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A
Applicant	Philips Medical Systems
Product code	MKJ
Device class	Class III
Decision date	Jan 17, 2002
Decision	Substantially Equivalent - Subject to Tracking Reg.
Regulation	870.5310

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Source

View the full FDA submission: accessdata.fda.gov

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HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A

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