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510(k) K935283

YOKE ASSEMBLY MEDICAL GAS by American Gage & Medical, Inc. — Product Code CAM

K935283 is an FDA 510(k) premarket notification submitted by American Gage & Medical, Inc. for the device "YOKE ASSEMBLY MEDICAL GAS". The FDA issued a decision of Substantially Equivalent on March 11, 1994. The device falls under product code CAM (Yoke Assembly, Medical Gas), a Class I device regulated under 21 CFR 868.6885.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1994
Date Received
November 3, 1993
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 for product code CAM

  • K851215 — T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER (June 18, 1985)
  • K851219 — FILL HOSE SAFETY 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