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510(k) K893713

NOVA OXYGEN TENT by Nova Health Systems, Inc. — Product Code BYL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1989
Date Received
May 18, 1989
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 Nova Health Systems, Inc.

  • K895477 — NOVA PILLOW (January 10, 1990)
  • K780502 — NOVA AIR FLOATATION SYSTEM (April 10, 1978)

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)
  • 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)