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510(k) K833923

MARZ-175 ARTERIAL BLOOD GAS SYRINGE by Chesebrough-Pond'S U.S.A. Co. — Product Code CBT

K833923 is an FDA 510(k) premarket notification submitted by Chesebrough-Pond'S U.S.A. Co. for the device "MARZ-175 ARTERIAL BLOOD GAS SYRINGE". The FDA issued a decision of Substantially Equivalent on January 9, 1984. The device falls under product code CBT (Arterial Blood Sampling Kit), a Class I device regulated under 21 CFR 868.1100. Chesebrough-Pond'S U.S.A. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1984
Date Received
November 14, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Arterial Blood Sampling Kit
Device Class
Class I
Regulation Number
868.1100
Review Panel
AN
Submission Type

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Other clearances by Chesebrough-Pond'S U.S.A. Co.

  • K863866 — RESPIRADYNE II(TM) (January 28, 1987)
  • K862803 — CHESEBROUGH POND'S HYDROCOLLOID DRESSING (November 14, 1986)
  • K851383 — BLISTERFILM TRANSPARENT DRESSING (July 5, 1985)
  • K851382 — CHESEBROUGH-POND'S SEQUENTIAL WOUND DRESSING (July 5, 1985)
  • K851539 — CHESEBROUGH-PONDS KANGAROO PUMP SET W/EASY-CAP CLO (June 12, 1985)
  • K843567 — KANGAROO NASOGASTRIC FEEDING TUBE (February 14, 1985)
  • K844186 — CONTINENT STOMA SYSTEM & ACCESSORIES (January 15, 1985)
  • K845010 — CHESEBROUGH-POND'S URI-DRAIN MALE URINARY POUCH (January 15, 1985)
  • K844789 — KANGAROO ACCESS II ENTERAL FEEDING CONTAINER (January 2, 1985)
  • K843128 — FEMALE URINARY INCONTINENCE SYS (January 2, 1985)

Other clearances for product code CBT

  • K071269 — HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM (August 1, 2007)
  • K070340 — SECURE ARTERIAL BLOOD SAMPLING SYSTEM (March 15, 2007)
  • K955663 — ABC IN-LINE BLOOD SAMPLING KIT (March 17, 1997)
  • K954015 — ABG POINT LOK NEEDLE PROTECTION DEVICE (November 20, 1995)
  • K954035 — ACTI-FLEX ARTERIAL EXTENSION SET (September 25, 1995)
  • K950098 — NEEDLE SAFETY COVER (August 11, 1995)
  • K945719 — ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM (March 16, 1995)
  • K944941 — PISTON SYRINGE (December 5, 1994)
  • K945485 — ABG NEEDLE PROTECTION (November 29, 1994)
  • K940575 — ASPIR-PULSE(TM) SAF-T-VENT (March 22, 1994)

FDA data resources