510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K102111Substantially Equivalent

Medical Magnetic Tape Recorder

Wpr Medical AS, Ne MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K102111 is the FDA 510(k) clearance record for MEDICAL MAGNETIC TAPE RECORDER, a class II device, cleared for Wpr Medical AS on under FDA product code DSI (Detector And Alarm, Arrhythmia). FDA records list one 510(k) clearance for Wpr Medical AS. As of , FDA records show no recalls naming K102111.

Clearance record

Decision date
Received
(132 days to decision)
Product code
DSI Detector And Alarm, Arrhythmia
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Applicant
Wpr Medical AS 435 Rice Creek Ter., Ne MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DSI

Trailing 12 months
1 clearance under product code DSI in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260