PRESSURE INFUSOR #1900— 510(k) K860084

Substantially Equivalent

Pa Medical Corp.

FDA 510(k) clearance K860084 for PRESSURE INFUSOR #1900, Substantially Equivalent on 1986-03-18. Applicant: Pa Medical Corp.. Device class: 1.

Clearance details

Applicant
Pa Medical Corp.
Product code
Code KZD
Device class
Class 1
Regulation
21 CFR 880.5420
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Columbia, TN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KZD

product code KZD
Death
4
Total
4

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.