PRECISION MED PRODUCTS, LTD. ADULT GAS SAMPLING— 510(k) K932497

Name: FDA 510(k) clearance K932497
Creator: U.S. Food and Drug Administration
Published: 1993-07-22

Substantially Equivalent

Precision Med Products, Ltd.

FDA 510(k) clearance K932497 for PRECISION MED PRODUCTS, LTD. ADULT GAS SAMPLING, Substantially Equivalent on 1993-07-22. Applicant: Precision Med Products, Ltd.. Device class: 1.

Clearance details

Applicant: Precision Med Products, Ltd.
Product code: Code CAI
Device class: Class 1
Regulation: 21 CFR 868.5240
Advisory panel: Anesthesiology
Date received: 1993-05-24
Decision date: 1993-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marrtinsville, IN, US

Download summary PDF View on FDA.gov ↗

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K954480 — CONDENSATE COLLECTION KIT1995-12-29
K953787 — UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT1995-09-19
K953788 — UNICOR, INC. GAS SAMPLING LINES & CONNECTORS1995-09-19
K952014 — PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS1995-05-22
K952016 — PRIMA PEDIATRIC GAS SAMPLING CIRCUITS1995-05-22

More clearances from Precision Med Products, Ltd.

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K932706 — PRECISION MED PRODUCTS LTD. VENTILATOR HOSE1993-07-23
K932707 — ADULT ANESTHESIA BREATHING CIRCUIT1993-07-23
K932708 — PRECISION MED PRODUCTS LTD MAPLESON D CIRCUITS1993-07-23
K932709 — PRECISION MED PRODUCTS LTD HYPERINFLATION SYSTEM1993-07-23
K932710 — GAS SAMPLING LINES AND CONNECTORS1993-07-23

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.