Home / 510(k) Clearances / K962182

510(k) K962182

BURLEW INFANT HOOD by Promedic, Inc. — Product Code FOG

K962182 is an FDA 510(k) premarket notification submitted by Promedic, Inc. for the device "BURLEW INFANT HOOD". The FDA issued a decision of Substantially Equivalent on Jul 15, 1996. The device falls under product code FOG (Hood, Oxygen, Infant), a Class I device regulated under 21 CFR 868.5700. Promedic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 15, 1996
Date Received
Jun 6, 1996
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 Promedic, Inc.

  • K131889 — EUM 100PRO (Apr 23, 2014)
  • K112318 — CLEARPATH 24 (Jun 29, 2012)
  • K072756 — NON-IV ADAPTER FOR INFANT NG TUBE (Dec 19, 2007)
  • K060497 — BABYAIR (Jul 11, 2006)
  • K060842 — REVJET TURBO (Jun 21, 2006)
  • K052903 — PEDIATRIC FEEDING TUBE (Nov 9, 2005)
  • K031409 — URINARY CATHETERS (Jun 17, 2003)
  • K024190 — FENESTRATED INFUSION CATHETER (Mar 17, 2003)
  • K023579 — GAS SAMPLING LINES (Jan 28, 2003)
  • K020005 — INFANT FEEDING TUBES (Jul 16, 2002)

Other clearances for product code FOG

  • K973128 — OLYMPUS NA-10J-1 ASPIRATION NEEDLE (Nov 18, 1997)
  • K955482 — SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION) (Jan 30, 1996)
  • K830781 — ENDO-GUARD (Mar 31, 1983)
  • K792144 — DISPOSA-HOOD (Dec 5, 1979)
  • K791861 — OXYGEN HOODS (Oct 4, 1979)
  • K790860 — RT-HOOD (May 29, 1979)
  • K780220 — HOOD, INFANT OXYGEN (Apr 10, 1978)
  • K770754 — DUODENOSCOPE, MOLEL TX-6 (Apr 28, 1977)

FDA data resources