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510(k) K760329

MASK, DISPOSABLE OXYGEN THERAPY by Inhal-O-Tech Medical Plastic — Product Code BYG

K760329 is an FDA 510(k) premarket notification submitted by Inhal-O-Tech Medical Plastic for the device "MASK, DISPOSABLE OXYGEN THERAPY". The FDA issued a decision of Substantially Equivalent on September 30, 1976. The device falls under product code BYG (Mask, Oxygen), a Class I device regulated under 21 CFR 868.5580. Inhal-O-Tech Medical Plastic has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1976
Date Received
July 28, 1976
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 Inhal-O-Tech Medical Plastic

  • K781741 — MASK, BI FLO NASAL OXYGEN (December 1, 1978)
  • K781394 — DISPOSABLE INCENTIVE SPIROMETER (October 16, 1978)
  • K781395 — DISPOSABLE AEROSOL T BRIGGS ADAPTOR (August 31, 1978)
  • K770354 — TUBING, AEROSAL, DISPOSABLE (March 16, 1977)
  • K770353 — DISPOSABLE TEMPERATURE PROBE (March 16, 1977)
  • K760330 — CANNULA, DISPOSABLE OXYGEN TTHERAPY (August 4, 1976)

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