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510(k) K780365

OXYGEN/NITROUS OXIDE OUTLET by Spica, Inc. — Product Code CAM

K780365 is an FDA 510(k) premarket notification submitted by Spica, Inc. for the device "OXYGEN/NITROUS OXIDE OUTLET". The FDA issued a decision of Substantially Equivalent on March 30, 1978. The device falls under product code CAM (Yoke Assembly, Medical Gas), a Class I device regulated under 21 CFR 868.6885. Spica, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1978
Date Received
March 6, 1978
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 Spica, Inc.

  • K800801 — ANALGESIA UNITS, OXYGEN & NITRATE DEVICE (May 28, 1980)
  • K780364 — MANIFOLD KIT (March 30, 1978)

Other clearances for product code CAM

  • K935283 — YOKE ASSEMBLY MEDICAL GAS (March 11, 1994)
  • 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)
  • K851219 — FILL HOSE SAFETY ADAPTER (June 18, 1985)
  • K840326 — GAS SUPPLY MANIFOLD SIEMENS-ELEMA AB (June 7, 1984)
  • K770426 — OXYGEN MANIFOLD SYSTEMS, NITROUS OXIDE (March 15, 1977)

FDA data resources