510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K004017Substantially Equivalent

H-Scribe

Mortara Instrument, Inc., Milwaukee WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K004017 is the FDA 510(k) clearance record for H-SCRIBE, a class II device, cleared for Mortara Instrument, Inc. on under FDA product code MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm). FDA records list 51 510(k) clearances for Mortara Instrument, Inc., from to . As of , FDA records show 2 recalls naming K004017.

Clearance record

Decision date
Received
(166 days to decision)
Product code
MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Regulation
21 CFR 870.2800
Device class
Class II
Review panel
Cardiovascular
Applicant
Mortara Instrument, Inc. 7865 N. 86th St., Milwaukee WI
510(k) summary
Summary
Third party review
No

Clearances, product code MLO

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