VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES— 510(k) K031740

Substantially Equivalent

Welch Allyn Protocol, Inc.

FDA 510(k) clearance K031740 for VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES, Substantially Equivalent on 2003-08-26. Applicant: Welch Allyn Protocol, Inc.. Device class: 2.

Clearance details

Applicant
Welch Allyn Protocol, Inc.
Product code
Code DQA
Device class
Class 2
Regulation
21 CFR 870.2700
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Beaverton, OR, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code DQA

view all

More clearances from Welch Allyn Protocol, Inc.

view all

Adverse events under product code DQA

product code DQA
Death
66
Malfunction
2,867
Other
1
Total
2,934

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.