PRIMA HYUPERINFLATION SYSTEM— 510(k) K952021

Substantially Equivalent

Prima, Inc.

FDA 510(k) clearance K952021 for PRIMA HYUPERINFLATION SYSTEM, Substantially Equivalent on 1995-05-22. Applicant: Prima, Inc.. Device class: 2.

Clearance details

Applicant: Prima, Inc.
Product code: Code BZR
Device class: Class 2
Regulation: 21 CFR 868.5330
Advisory panel: Anesthesiology
Date received: 1995-04-28
Decision date: 1995-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, TN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Prima, Inc.

K952010 — PRIMA VENTILATOR HOSES1995-05-22
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K952012 — PRIMA CUSTOM ANESTESIA CIRCUIT1995-05-22
K952013 — PRIMA GUEDEL AIRWAYS1995-05-22
K952014 — PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS1995-05-22

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