PRIMA MAPLESON D CIRCUIT— 510(k) K952017

Name: FDA 510(k) clearance K952017
Creator: U.S. Food and Drug Administration
Published: 1995-05-22

Substantially Equivalent

Prima, Inc.

FDA 510(k) clearance K952017 for PRIMA MAPLESON D CIRCUIT, Substantially Equivalent on 1995-05-22. Applicant: Prima, Inc.. Device class: 1.

Clearance details

Applicant: Prima, Inc.
Product code: Code CAI
Device class: Class 1
Regulation: 21 CFR 868.5240
Advisory panel: Anesthesiology
Date received: 1995-04-28
Decision date: 1995-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, TN, US

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K952014 — PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS1995-05-22
K952016 — PRIMA PEDIATRIC GAS SAMPLING CIRCUITS1995-05-22

More clearances from Prima, Inc.

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K952010 — PRIMA VENTILATOR HOSES1995-05-22
K952011 — PRIMA BREATHING BAGS1995-05-22
K952012 — PRIMA CUSTOM ANESTESIA CIRCUIT1995-05-22
K952013 — PRIMA GUEDEL AIRWAYS1995-05-22
K952015 — PRIMA FILTER1995-05-22

Adverse events under product code CAI

product code CAI

Malfunction: 869
Other: 1
Total: 870

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.