TRACH MASK MODEL (245, 246)— 510(k) K955483

Substantially Equivalent

Hospitak, Inc.

FDA 510(k) clearance K955483 for TRACH MASK MODEL (245, 246), Substantially Equivalent on 1996-02-28. Applicant: Hospitak, Inc.. Device class: 1.

Clearance details

Applicant: Hospitak, Inc.
Product code: Code BYF
Device class: Class 1
Regulation: 21 CFR 868.5600
Advisory panel: Anesthesiology
Date received: 1995-12-01
Decision date: 1996-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Farmingdale, NY, US

Download summary PDF View on FDA.gov ↗

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More clearances from Hospitak, Inc.

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K915750 — DISPOSABLE BACTERIAL BREATHNG FILTER1994-11-30
K920842 — AEROSOL DELIVERY SYSTEMS1992-05-15

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