DeviceClearance

H12+ HOLTER RECORDER— 510(k) K050896

Substantially Equivalent

Mortara Instrument, Inc.

FDA 510(k) clearance K050896 for H12+ HOLTER RECORDER, Substantially Equivalent on 2005-08-24. Applicant: Mortara Instrument, Inc.. Device class: 2.

Clearance details

Applicant
Mortara Instrument, Inc.
Product code
Code DSH
Device class
Class 2
Regulation
21 CFR 870.2800
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Milwaukee, WI, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code DSH

view all

More clearances from Mortara Instrument, Inc.

view all

Adverse events under product code DSH

product code DSH
Death
3
Injury
652
Total
655

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K050896

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050896.

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