Home / 510(k) Clearances / K894642

510(k) K894642

SLEEPAP MASK by Medical Industries America, Inc. — Product Code BYG

K894642 is an FDA 510(k) premarket notification submitted by Medical Industries America, Inc. for the device "SLEEPAP MASK". The FDA issued a decision of Substantially Equivalent on October 19, 1989. The device falls under product code BYG (Mask, Oxygen), a Class I device regulated under 21 CFR 868.5580. Medical Industries America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1989
Date Received
July 24, 1989
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 Medical Industries America, Inc.

  • K050990 — REMREST HEATED HUMIDIFIER (May 2, 2005)
  • K032170 — TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000 (May 28, 2004)
  • K002763 — REMREST (May 4, 2001)
  • K011053 — OPTIMA (April 20, 2001)
  • K964078 — 3050 SPORT-NEB (January 10, 1997)
  • K943990 — 3000 AEROSOL TWO (March 21, 1995)
  • K942444 — 3002 AEROMAX (March 10, 1995)
  • K941961 — 605 VACU-MAX (March 2, 1995)
  • K942208 — 4003 AEROLITE (February 24, 1995)
  • K940630 — 503 MAXI COMPRESSOR (February 21, 1995)

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)
  • K940887 — SYSTEM 22 ADULT MASK (April 19, 1994)
  • K940888 — SYSTEM 22 PAEDIATRIC MASK (April 19, 1994)
  • K931952 — MEDWAY OXYGEN MASK (August 20, 1993)

FDA data resources