OXYGEN MASKS— 510(k) K823141

Name: FDA 510(k) clearance K823141
Creator: U.S. Food and Drug Administration
Published: 1982-11-29

Substantially Equivalent

Seven Harvest Intl. Import & Export

FDA 510(k) clearance K823141 for OXYGEN MASKS, Substantially Equivalent on 1982-11-29. Applicant: Seven Harvest Intl. Import & Export. Device class: 1.

Clearance details

Applicant: Seven Harvest Intl. Import & Export
Product code: Code BYG
Device class: Class 1
Regulation: 21 CFR 868.5580
Advisory panel: Anesthesiology
Date received: 1982-10-25
Decision date: 1982-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BYG

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K963298 — FIRST AID KIT(S)1996-11-06
K962848 — HANS RUDOLPH NASAL CPAP MASK1996-10-16
K945482 — DISPOSABLE, CPAP OXYGEN MASK1995-09-19
K953464 — WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK1995-09-18
K953039 — VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS1995-09-15

More clearances from Seven Harvest Intl. Import & Export

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K940793 — DOUBLE TRACH SWIVEL CONNECTOR1994-07-01
K823506 — NASAL CANNULA1982-12-09
K823142 — OXYGEN TUBINGS1982-11-29
K823143 — BUBBLE HUMIDIFIERS1982-11-29
K820709 — AIRWAYS1982-06-25

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