H-SCRIBE— 510(k) K004017

Substantially Equivalent

Mortara Instrument, Inc.

FDA 510(k) clearance K004017 for H-SCRIBE, Substantially Equivalent on 2001-06-11. Applicant: Mortara Instrument, Inc.. Device class: 2.

Clearance details

Applicant: Mortara Instrument, Inc.
Product code: Code MLO
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2000-12-27
Decision date: 2001-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MLO

K261580 — ZBPro Diagnostic (Version 2.0)2026-09-11
K241890 — Philips Holter Analysis System2025-03-21
K240794 — Frontier X Plus2024-11-08
K200833 — RX-1 Rhythm Express Remote Cardiac Monitoring System2020-09-02
K193177 — CER-S2020-08-26

More clearances from Mortara Instrument, Inc.

K182297 — Surveyor S22019-01-24
K173765 — Surveyor Patient Monitor2018-09-04
K161517 — Mortara Surveyor Patient Monitor2017-01-11
K161465 — CardioConfirm2016-09-03
K160685 — Surveyor S4 Mobile Monitor2016-08-04

Recalls naming K004017

K-number listed on FDA's recall record

Z-0320-2025 — Hillrom Welch Allyn HScribe Holter System; ambulatory monitoringClass II·Ongoing·Baxter Healthcare Corporation·20241011
Z-0323-2025 — Hillrom Welch Allyn Vision Express Holter Analysis System; ElectrocardiographClass II·Ongoing·Baxter Healthcare Corporation·20241011

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K004017.

Data sourced from openFDA. This site is unofficial and independent of the FDA.