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510(k) K890108

MODIFIED CUSHION-FLEX(TM) by Life Design Systems, Inc. — Product Code BSJ

K890108 is an FDA 510(k) premarket notification submitted by Life Design Systems, Inc. for the device "MODIFIED CUSHION-FLEX(TM)". The FDA issued a decision of Substantially Equivalent on January 24, 1989. The device falls under product code BSJ (Mask, Gas, Anesthetic), a Class I device regulated under 21 CFR 868.5550. Life Design Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1989
Date Received
January 3, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Gas, Anesthetic
Device Class
Class I
Regulation Number
868.5550
Review Panel
AN
Submission Type

Other clearances by Life Design Systems, Inc.

  • K913714 — MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM) (December 1, 1992)
  • K885313 — HUMIDI-FLEX TM (October 11, 1989)
  • K893030 — CHILD SIZE - FILTER FLEX (TM) (September 18, 1989)
  • K892862 — FLEX-CUP PERCUSSOR (May 25, 1989)
  • K892221 — PULMONARY RESUSCITATOR, MODIFICATION (May 18, 1989)
  • K890011 — OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING (March 20, 1989)
  • K884387 — CUSHION FLEX(TM) (November 17, 1988)
  • K884068 — PULMANEX TM (NEO-NATAL SIZE) (November 16, 1988)
  • K873179 — HEATER WIRE BREATHING CIRCUIT (March 31, 1988)
  • K863857 — PULSE-OX (October 7, 1987)

Other clearances for product code BSJ

  • K163277 — SuperNO2VA Device (October 13, 2017)
  • K953107 — ANESTHESIA/RESPIRATORY FACE MASK (August 15, 1995)
  • K953295 — ANESTHESIA FACE MASK (August 11, 1995)
  • K952689 — BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK (July 11, 1995)
  • K951043 — AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK (June 7, 1995)
  • K950771 — DISPOSABLE ADHESIVE FACE MASK (March 10, 1995)
  • K945894 — MASK, GAS, ANESTHETIC (January 27, 1995)
  • K945440 — DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK (November 8, 1994)
  • K944157 — DISPOSABLE, PREFORMED FACE MASK (October 3, 1994)
  • K932147 — NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE (August 20, 1993)

FDA data resources