Atlas FDA

MODEL EC4542G MINIATURE

FDA 510(k) clearance K896352 · decided 1990-01-24

Clearance details

K-number
K896352
Device name
MODEL EC4542G MINIATURE
Applicant
Pace Medical
Decision
Substantially Equivalent
Date received
1989-11-06
Decision date
1990-01-24
Days to decision
79 days
Clearance type
Traditional
Product code
DTE
Device class
2
Regulation number
870.3600
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Waltham, MA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
Solo Pace Control (K241781)Solo Pace, Inc.2025-01-10
Lifetech Cardio Temporary Pacemaker (K232721)Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.2024-01-07
Medtronic Model 5392 External Pulse Generator (EPG) (K201011)Medtronic, Inc.2020-05-13
Medtronic Model 5392 External Pulse Generator (EPG) (K190825)Medtronic, Inc.2019-04-30
Lifetech Cardio Model 8301 Temporary Pacemaker (K182839)Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.2019-02-28
Medtronic Model 5392 External Pulse Generator (EPG) (K181973)Medtronic, Inc.2018-08-21
Medtronic Model 53401 External Pulse Generator (EPG) (K180873)Medtronic, Inc.2018-04-19
Medtronic Temporary External Pacemaker 53401 (K162054)Medtronic, Inc.2016-10-18
Medtronic Model 5392 External Pulse Generator (EPG) (K162550)Medtronic, Inc.2016-10-12
Medtronic Model 5392 External Pulse Generator (EPG) (K150246)Medtronic, Inc.2015-02-18
MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) (K132924)Medtronic, Inc.2013-10-31
PSA SERIES (K123916)Osypka Medical, Inc.2013-04-09

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
MICRO-PACE MODEL 4580 DUAL-CHAMBER,DDD,TEMPORARY CARDIAC PACEMAKER (P920032/S008)Pace Medical2002-02-20
BEDSIDE(TM) SINGLE CHAMBER, TXTERNAL PULSE GENERATOR, MODEL 4170 (P920032/S007)Pace Medical2001-10-26
MODEL4553 MICRO-PACE,DUAL-CHAMBER,DDD TEMPORARY CARDIAC PACEMAKER (P920032/S006)Pace Medical2001-04-06
MICRO-PACE DUAL-CHAMBER, DDD, TEMPORARY CARDIAC PACEMAKER (P920032/S005)Pace Medical2000-02-02
MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER (P920032/S004)Pace Medical1998-02-27
MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER (P920032/S003)Pace Medical1996-07-19
MICRO-PACE MODEL 4553 DUAL CHAMBER DDD TEMPORARY CARDIAC PACEMAKER (P920032/S002)Pace Medical1996-04-26
MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER (P920032/S001)Pace Medical1995-08-28