PRIMA VOLUMN VENTILATORSS— 510(k) K952022

Substantially Equivalent

Prima, Inc.

FDA 510(k) clearance K952022 for PRIMA VOLUMN VENTILATORSS, Substantially Equivalent on 1995-05-22. Applicant: Prima, Inc.. Device class: 1.

Clearance details

Applicant: Prima, Inc.
Product code: Code BZO
Device class: Class 1
Regulation: 21 CFR 868.5975
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 ↗

Recent devices under product code BZO

K953784 — UNICOR, INC. CORRUGATED TUBING1995-09-19
K953785 — UNICOR, INC. VENTILATOR HOSES1995-09-18
K952010 — PRIMA VENTILATOR HOSES1995-05-22
K952011 — PRIMA BREATHING BAGS1995-05-22
K952012 — PRIMA CUSTOM ANESTESIA CIRCUIT1995-05-22

More clearances from Prima, Inc.

K952013 — PRIMA GUEDEL AIRWAYS1995-05-22
K952014 — PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS1995-05-22
K952015 — PRIMA FILTER1995-05-22
K952016 — PRIMA PEDIATRIC GAS SAMPLING CIRCUITS1995-05-22
K952017 — PRIMA MAPLESON D CIRCUIT1995-05-22

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