Atlas FDA

EXTERNAL PULSE GENERATOR FOR TEMP. STIM

FDA 510(k) clearance K831768 · decided 1983-12-16

Clearance details

K-number
K831768
Device name
EXTERNAL PULSE GENERATOR FOR TEMP. STIM
Applicant
Oscor, Inc.
Decision
Substantially Equivalent
Date received
1983-06-01
Decision date
1983-12-16
Days to decision
198 days
Clearance type
Traditional
Product code
DTE
Device class
2
Regulation number
870.3600
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Palm Harbor, FL, 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.