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510(k) K955482

SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION) by Advantage Medical Services, Inc. — Product Code FOG

K955482 is an FDA 510(k) premarket notification submitted by Advantage Medical Services, Inc. for the device "SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION)". The FDA issued a decision of Substantially Equivalent on January 30, 1996. The device falls under product code FOG (Hood, Oxygen, Infant), a Class I device regulated under 21 CFR 868.5700.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1996
Date Received
November 1, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hood, Oxygen, Infant
Device Class
Class I
Regulation Number
868.5700
Review Panel
AN
Submission Type

Other clearances for product code FOG

  • K973128 — OLYMPUS NA-10J-1 ASPIRATION NEEDLE (November 18, 1997)
  • K962182 — BURLEW INFANT HOOD (July 15, 1996)
  • K830781 — ENDO-GUARD (March 31, 1983)
  • K792144 — DISPOSA-HOOD (December 5, 1979)
  • K791861 — OXYGEN HOODS (October 4, 1979)
  • K790860 — RT-HOOD (May 29, 1979)
  • K780220 — HOOD, INFANT OXYGEN (April 10, 1978)
  • K770754 — DUODENOSCOPE, MOLEL TX-6 (April 28, 1977)

FDA data resources