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510(k) K780220

HOOD, INFANT OXYGEN by Shiley, Inc. — Product Code FOG

K780220 is an FDA 510(k) premarket notification submitted by Shiley, Inc. for the device "HOOD, INFANT OXYGEN". The FDA issued a decision of Substantially Equivalent on April 10, 1978. The device falls under product code FOG (Hood, Oxygen, Infant), a Class I device regulated under 21 CFR 868.5700. Shiley, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1978
Date Received
February 10, 1978
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 by Shiley, Inc.

  • K920594 — SHILEY PERFUSION TUBING SETS (March 18, 1993)
  • K910991 — SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM (November 27, 1991)
  • K911876 — SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200 (August 9, 1991)
  • K910923 — BCD ADVANCED (April 9, 1991)
  • K901548 — BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS (January 14, 1991)
  • K903435 — SHILEY SPECIALIZED TRACHEOSTOMY TUBE (October 2, 1990)
  • K901624 — SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY. (July 3, 1990)
  • K901249 — PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR (June 11, 1990)
  • K901250 — PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR (June 11, 1990)
  • K900797 — STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR (May 10, 1990)

Other clearances for product code FOG

  • K973128 — OLYMPUS NA-10J-1 ASPIRATION NEEDLE (November 18, 1997)
  • K962182 — BURLEW INFANT HOOD (July 15, 1996)
  • K955482 — SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION) (January 30, 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)
  • K770754 — DUODENOSCOPE, MOLEL TX-6 (April 28, 1977)

FDA data resources