PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT— 510(k) K884525

Name: FDA 510(k) clearance K884525
Creator: U.S. Food and Drug Administration
Published: 1988-12-16

Substantially Equivalent

Intertech/Ohio

FDA 510(k) clearance K884525 for PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT, Substantially Equivalent on 1988-12-16. Applicant: Intertech/Ohio. Device class: 1.

Clearance details

Applicant: Intertech/Ohio
Product code: Code BZO
Device class: Class 1
Regulation: 21 CFR 868.5975
Advisory panel: Anesthesiology
Date received: 1988-10-27
Decision date: 1988-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Myers, FL, US

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K952011 — PRIMA BREATHING BAGS1995-05-22
K952012 — PRIMA CUSTOM ANESTESIA CIRCUIT1995-05-22

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