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510(k) K823141

OXYGEN MASKS by Seven Harvest Intl. Import & Export — Product Code BYG

K823141 is an FDA 510(k) premarket notification submitted by Seven Harvest Intl. Import & Export for the device "OXYGEN MASKS". The FDA issued a decision of Substantially Equivalent on November 29, 1982. The device falls under product code BYG (Mask, Oxygen), a Class I device regulated under 21 CFR 868.5580. Seven Harvest Intl. Import & Export has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1982
Date Received
October 25, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Oxygen
Device Class
Class I
Regulation Number
868.5580
Review Panel
AN
Submission Type

Other clearances by Seven Harvest Intl. Import & Export

  • K940793 — DOUBLE TRACH SWIVEL CONNECTOR (July 1, 1994)
  • K823506 — NASAL CANNULA (December 9, 1982)
  • K823142 — OXYGEN TUBINGS (November 29, 1982)
  • K823143 — BUBBLE HUMIDIFIERS (November 29, 1982)
  • K820709 — AIRWAYS (June 25, 1982)
  • K813074 — CONNECTORS & ADAPTERS (December 31, 1981)

Other clearances for product code BYG

  • K963298 — FIRST AID KIT(S) (November 6, 1996)
  • K962848 — HANS RUDOLPH NASAL CPAP MASK (October 16, 1996)
  • K945482 — DISPOSABLE, CPAP OXYGEN MASK (September 19, 1995)
  • K953464 — WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK (September 18, 1995)
  • K953039 — VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS (September 15, 1995)
  • K945472 — WESTMED PEDIATRIC AND ADULT AEROSOL MASK (February 7, 1995)
  • K942907 — JEMSDAL MASK (August 31, 1994)
  • K940888 — SYSTEM 22 PAEDIATRIC MASK (April 19, 1994)
  • K940887 — SYSTEM 22 ADULT MASK (April 19, 1994)
  • K931952 — MEDWAY OXYGEN MASK (August 20, 1993)

FDA data resources