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510(k) K882396

AEROSOL DELIVERY HOOD by Viratek, Inc. — Product Code BYL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 1988
Date Received
June 10, 1988
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 Viratek, Inc.

  • K896608 — SPAG PAK (April 9, 1990)
  • K871427 — (SPAG) MODEL SPAG-2 6000 SERIES (October 6, 1987)
  • K870051 — SPAG-2 AEROSOL GENERATOR W/USE OF VIRAZOLE (October 6, 1987)
  • K843717 — VIRATEK SMALL PARTICLE AEROSOL GENERAT (December 30, 1985)

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)
  • 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)