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510(k) K924541

EPIDURAL MINIPACK by Concord/Portex — Product Code BYO

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
July 9, 1993
Date Received
September 8, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bottle, Blow
Device Class
Class I
Regulation Number
868.5220
Review Panel
AN
Submission Type

Other clearances by Concord/Portex

  • K923559 — STERI-CATH MDI (October 25, 1993)
  • K930218 — SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES (July 27, 1993)
  • K930286 — DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS (June 22, 1993)
  • K923127 — NEEDLE-PRO CARTRIDGE (April 29, 1993)
  • K923910 — HEAT MOISTURE CONDENSER (January 26, 1993)
  • K922749 — LOW PROFILE TRACHEOSTOMY TUBE (September 2, 1992)
  • K922445 — VACU-PRO (August 12, 1992)
  • K915452 — ANESTHESIA BREATHING CIRCUIT (February 14, 1992)
  • K911809 — NEW-VENT (August 26, 1991)
  • K912124 — TRACHEOSTOMY TUBE AND CUFF (August 16, 1991)

Other clearances for product code BYO

  • K913527 — HYPERFREE (January 21, 1992)
  • K780558 — BOTTLE BREATHING DEVICE (May 26, 1978)
  • K780407 — 2C7125 BLOW BOTTLE (April 10, 1978)