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510(k) K851219

FILL HOSE SAFETY ADAPTER by Penox Technologies, Inc. — Product Code CAM

K851219 is an FDA 510(k) premarket notification submitted by Penox Technologies, Inc. for the device "FILL HOSE SAFETY ADAPTER". The FDA issued a decision of Substantially Equivalent on June 18, 1985. The device falls under product code CAM (Yoke Assembly, Medical Gas), a Class I device regulated under 21 CFR 868.6885. Penox Technologies, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1985
Date Received
March 26, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Yoke Assembly, Medical Gas
Device Class
Class I
Regulation Number
868.6885
Review Panel
AN
Submission Type

Other clearances by Penox Technologies, Inc.

  • K864667 — PENOX HOSPITAL BED (January 21, 1987)
  • K863978 — PORTABLE LIQUID OXYGEN UNIT (MODIFICATION) (December 15, 1986)
  • K862654 — MODIFIED PENOX LIFT CHAIR (July 18, 1986)
  • K853775 — PENOX HIGH FLOW MANIFOLD (November 29, 1985)
  • K852109 — PENOX PERFORMER WHEELCHAIR (August 22, 1985)
  • K851218 — PENOX LIFT CHAIR (June 21, 1985)
  • K851215 — T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER (June 18, 1985)
  • K851216 — PENOX DUAL FEED MANIFOLD (June 18, 1985)
  • K851217 — PENOX DUAL FLOW MINIFOLD (June 18, 1985)

Other clearances for product code CAM

  • K935283 — YOKE ASSEMBLY MEDICAL GAS (March 11, 1994)
  • K851215 — T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER (June 18, 1985)
  • K851216 — PENOX DUAL FEED MANIFOLD (June 18, 1985)
  • K851217 — PENOX DUAL FLOW MINIFOLD (June 18, 1985)
  • K840326 — GAS SUPPLY MANIFOLD SIEMENS-ELEMA AB (June 7, 1984)
  • K780365 — OXYGEN/NITROUS OXIDE OUTLET (March 30, 1978)
  • K770426 — OXYGEN MANIFOLD SYSTEMS, NITROUS OXIDE (March 15, 1977)

FDA data resources