PRESSURIZER— 510(k) K951988

Name: FDA 510(k) clearance K951988
Creator: U.S. Food and Drug Administration
Published: 1995-06-14

Substantially Equivalent

Promedic, Inc.

FDA 510(k) clearance K951988 for PRESSURIZER, Substantially Equivalent on 1995-06-14. Applicant: Promedic, Inc.. Device class: 1.

Clearance details

Applicant: Promedic, Inc.
Product code: Code KZD
Device class: Class 1
Regulation: 21 CFR 880.5420
Advisory panel: General Hospital
Date received: 1995-04-27
Decision date: 1995-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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K942933 — PRESSURE INFUSION CUFF1994-08-25
K930012 — KAWASUMI LABORATORIES K-CUFF1993-12-14

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Adverse events under product code KZD

product code KZD

Death: 4
Total: 4

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.