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510(k) K770426

OXYGEN MANIFOLD SYSTEMS, NITROUS OXIDE by Bel-Med, Inc. — Product Code CAM

K770426 is an FDA 510(k) premarket notification submitted by Bel-Med, Inc. for the device "OXYGEN MANIFOLD SYSTEMS, NITROUS OXIDE". The FDA issued a decision of Substantially Equivalent on March 15, 1977. The device falls under product code CAM (Yoke Assembly, Medical Gas), a Class I device regulated under 21 CFR 868.6885. Bel-Med, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1977
Date Received
March 7, 1977
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 Bel-Med, Inc.

  • K821801 — NORSEN DEBRIDER (July 28, 1982)

Other clearances for product code CAM

  • K935283 — YOKE ASSEMBLY MEDICAL GAS (March 11, 1994)
  • K851219 — FILL HOSE SAFETY ADAPTER (June 18, 1985)
  • K851216 — PENOX DUAL FEED MANIFOLD (June 18, 1985)
  • K851217 — PENOX DUAL FLOW MINIFOLD (June 18, 1985)
  • K851215 — T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER (June 18, 1985)
  • K840326 — GAS SUPPLY MANIFOLD SIEMENS-ELEMA AB (June 7, 1984)
  • K780365 — OXYGEN/NITROUS OXIDE OUTLET (March 30, 1978)

FDA data resources