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510(k) K905627

NASCOR OXYDOME by Nascor Pty. , Ltd. — Product Code BYL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1991
Date Received
December 14, 1990
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

Other clearances by Nascor Pty. , Ltd.

  • K935126 — NASCOR IGLOO (October 18, 1994)

Other clearances for product code BYL

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  • 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)
  • K851666 — MEDI-COMP NEONATAL OXYGEN HOOD (August 6, 1985)
  • K852345 — SEA-LONG NECKSEAL & HOOD (June 20, 1985)
  • K820640 — HOO2D SEAT-INFANT (March 26, 1982)
  • K802653 — MEDIUM SIZE OXYGEN HOOD #1547 (November 24, 1980)