510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MPEClass II

Auxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker

21 CFR 870.5550 / Cardiovascular
FDA source (opens on fda.gov)

MPE is the FDA product code for Auxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker, a class II device type, regulated under 21 CFR 870.5550. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
MPE
Device name
Auxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker
Regulation
21 CFR 870.5550
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code MPE

By decision year
1 clearance under product code MPE with a decision year between 1995 and 1995, 1995 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MPE by decision year
YearClearances
19951

Applicants with the most clearances

Product code MPE
Applicants holding the most 510(k) clearances under product code MPE
ApplicantClearances
Physio Control, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code MPE.