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510(k) K891316

ANESTHESIA/RESPIRATORY DISPOSABLE MASK by Concord/Portex — Product Code BSJ

K891316 is an FDA 510(k) premarket notification submitted by Concord/Portex for the device "ANESTHESIA/RESPIRATORY DISPOSABLE MASK". The FDA issued a decision of Substantially Equivalent on August 21, 1989. The device falls under product code BSJ (Mask, Gas, Anesthetic), a Class I device regulated under 21 CFR 868.5550. Concord/Portex has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1989
Date Received
March 13, 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 Concord/Portex

  • K923559 — STERI-CATH MDI (October 25, 1993)
  • K930218 — SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES (July 27, 1993)
  • K924541 — EPIDURAL MINIPACK (July 9, 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)

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