DeviceClearance

Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems— 510(k) K152944

Substantially Equivalent

Mortara Instrument, Inc.

FDA 510(k) clearance K152944 for Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems, Substantially Equivalent on 2016-01-06. Applicant: Mortara Instrument, Inc.. Device class: 2.

Clearance details

Applicant
Mortara Instrument, Inc.
Product code
Code DPS
Device class
Class 2
Regulation
21 CFR 870.2340
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Milwaukee, WI, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DPS

product code DPS
Death
7
Total
7

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 K152944

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 K152944.

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