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510(k) K851666

MEDI-COMP NEONATAL OXYGEN HOOD by Medicomp, Inc. — Product Code BYL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1985
Date Received
April 23, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K943915 — HEAT AND MOISTURE EXCHANGER FILTER (HME) (October 14, 1994)
  • K900207 — EPICARDIA 4000 (July 31, 1990)
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Other clearances for product code BYL

  • K935126 — NASCOR IGLOO (October 18, 1994)
  • K905627 — NASCOR OXYDOME (June 3, 1991)
  • K896608 — SPAG PAK (April 9, 1990)
  • K895866 — DIRD INGANT O2 (BIO 2 HOOD) (October 27, 1989)
  • K893713 — NOVA OXYGEN TENT (August 21, 1989)
  • K893714 — KEYSTONE OXYGEN TENT (August 21, 1989)
  • K882396 — AEROSOL DELIVERY HOOD (August 1, 1988)
  • K852345 — SEA-LONG NECKSEAL & HOOD (June 20, 1985)
  • K820640 — HOO2D SEAT-INFANT (March 26, 1982)
  • K802653 — MEDIUM SIZE OXYGEN HOOD #1547 (November 24, 1980)