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510(k) K781741

MASK, BI FLO NASAL OXYGEN by Inhal-O-Tech Medical Plastic — Product Code BYG

K781741 is an FDA 510(k) premarket notification submitted by Inhal-O-Tech Medical Plastic for the device "MASK, BI FLO NASAL OXYGEN". The FDA issued a decision of Substantially Equivalent on Dec 1, 1978. 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
Dec 1, 1978
Date Received
Oct 7, 1978
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

  • K781394 — DISPOSABLE INCENTIVE SPIROMETER (Oct 16, 1978)
  • K781395 — DISPOSABLE AEROSOL T BRIGGS ADAPTOR (Aug 31, 1978)
  • K770354 — TUBING, AEROSAL, DISPOSABLE (Mar 16, 1977)
  • K770353 — DISPOSABLE TEMPERATURE PROBE (Mar 16, 1977)
  • K760329 — MASK, DISPOSABLE OXYGEN THERAPY (Sep 30, 1976)
  • K760330 — CANNULA, DISPOSABLE OXYGEN TTHERAPY (Aug 4, 1976)

Other clearances for product code BYG

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

FDA data resources