ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413

FDA 510(k) clearance K000660 · decided 2000-03-28

Clearance details

K-number: K000660
Device name: ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413
Applicant: Medical Data Electronics
Decision: Substantially Equivalent
Date received: 2000-02-28
Decision date: 2000-03-28
Days to decision: 29 days
Clearance type: Special
Product code: DRO
Device class: 2
Regulation number: 870.5550
Medical specialty: Cardiovascular
Advisory committee: Cardiovascular
Location: Arleta, CA, US
Third-party review: No
Expedited review: No

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Devices cleared under the same product code - the starting set for predicate research.

Record	Firm	Date
LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES (K012218)	The Ludlow Company LP	2001-10-12
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 (K012404)	Katecho, Inc.	2001-10-12
PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) (K983196)	Tz Medical, Inc.	1999-09-15
PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT (K983232)	Tz Medical, Inc.	1999-09-15
PORTABLE INTENSIVE CARE UNIT (K974034)	Medical Research Laboratories, Inc.	1998-03-02
CARDIOSERV P (K962547)	Marquette Electronics, Inc.	1997-03-06
RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM (K963120)	Marquette Electronics, Inc.	1997-02-28
ESORT II + 400 SERIES MONITOR (K961138)	Medical Data Electronics	1996-12-10
ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000 (K950856)	Zoll Medical Corp	1995-12-29
LIFEPAK 11 (K951593)	Physio-Control Corp.	1995-12-29
HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR (K950483)	Hewlett-Packard Co.	1995-05-22
K-DEFIB/PACE CARBON ELECTRODE (K926175)	Katecho, Inc.	1993-04-15

No recalls on record reference this clearance.