Atlas FDA

OPTIMA MPT MODEL 5281E AND MODEL 5282E

FDA 510(k) clearance K897116 · decided 1990-03-14

Clearance details

K-number
K897116
Device name
OPTIMA MPT MODEL 5281E AND MODEL 5282E
Applicant
Telectronics Pacing Systems, Inc.
Decision
Substantially Equivalent
Date received
1989-12-26
Decision date
1990-03-14
Days to decision
78 days
Clearance type
Traditional
Product code
DXY
Device class
3
Regulation number
870.3610
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Englewood, CO, US
Third-party review
No
Expedited review
No

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RecordFirmDate
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB. (P940024)Telectronics Pacing Systems, Inc.1997-07-03
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S032)Telectronics Pacing Systems, Inc.1990-05-09
SEQUICOR SERIES PULSE GEN. MODELS 233F,233G,& 240G (P820014/S044)Telectronics Pacing Systems, Inc.1990-05-09
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S030)Telectronics Pacing Systems, Inc.1990-03-22
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S042)Telectronics Pacing Systems, Inc.1990-03-22
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S031)Telectronics Pacing Systems, Inc.1990-02-02
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S043)Telectronics Pacing Systems, Inc.1990-02-02
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S041)Telectronics Pacing Systems, Inc.1989-04-18