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510(k) K874092

MASK, OXYGEN by Life Support Products, Inc. — Product Code BYG

K874092 is an FDA 510(k) premarket notification submitted by Life Support Products, Inc. for the device "MASK, OXYGEN". The FDA issued a decision of Substantially Equivalent on February 11, 1988. The device falls under product code BYG (Mask, Oxygen), a Class I device regulated under 21 CFR 868.5580. Life Support Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1988
Date Received
October 8, 1987
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 Life Support Products, Inc.

  • K941870 — LSPI AUTOMATIC VENTILATOR, MODEL AV2000-100 (January 9, 1995)
  • K941871 — LSPI AUTOMATIC VENTILATOR, MODEL AV3000-100 (January 9, 1995)
  • K940934 — LIFE VAC (May 3, 1994)
  • K936187 — LSPI PRESSURE REGULATOR (January 27, 1994)
  • K932200 — LSPI AUTOMATIC VENTILATOR (November 24, 1993)
  • K932199 — LSPI AUTOMATIC VENTILATOR, MODEL AV3000 (November 24, 1993)
  • K922819 — INFANT DISPOSABLE BAG MASK RESUSCITATOR (November 24, 1993)
  • K922691 — LSP (MODEL 554) BAG MASK RESUSCITATOR (November 24, 1993)
  • K921553 — LSPI INFANT BAG MASK (October 19, 1992)
  • K921107 — AUTOVAC (September 17, 1992)

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