CANNULA, NASAL, OXYGEN— 510(k) K781415

Name: FDA 510(k) clearance K781415
Creator: U.S. Food and Drug Administration
Published: 1978-09-07

Substantially Equivalent

Vitalab Products Corp.

FDA 510(k) clearance K781415 for CANNULA, NASAL, OXYGEN, Substantially Equivalent on 1978-09-07. Applicant: Vitalab Products Corp.. Device class: 1.

Clearance details

Applicant: Vitalab Products Corp.
Product code: Code CAT
Device class: Class 1
Regulation: 21 CFR 868.5340
Advisory panel: Anesthesiology
Date received: 1978-08-15
Decision date: 1978-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K935533 — NASAL CANNULA1994-02-03
K922397 — 4 SURE TM NASAL OXYGEN CANNULA1993-03-18
K921496 — SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED1992-08-14
K920573 — CANNULA NASAL OXYGEN1992-08-11

More clearances from Vitalab Products Corp.

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K781416 — TUBING, FLEXIBLE, MEDICAL GAS1978-09-11
K781413 — MASK, PXYGEN1978-09-07
K781414 — MASK, OXYGEN, NONBREATHING1978-09-07

Adverse events under product code CAT

product code CAT

Death: 5
Malfunction: 544
Other: 2
Total: 551

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.