DeviceClearance

ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT— 510(k) K120774

Substantially Equivalent

Welch Allyn, Inc.

FDA 510(k) clearance K120774 for ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT, Substantially Equivalent on 2012-04-10. Applicant: Welch Allyn, Inc.. Device class: 2.

Clearance details

Applicant
Welch Allyn, Inc.
Product code
Code DSI
Device class
Class 2
Regulation
21 CFR 870.1025
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Skaneateles Falls, NY, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DSI

product code DSI
Death
170
Injury
729
Malfunction
10,680
Total
11,579

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 →

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