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510(k) K896608

SPAG PAK by Viratek, Inc. — Product Code BYL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1990
Date Received
November 21, 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 Viratek, Inc.

  • K882396 — AEROSOL DELIVERY HOOD (August 1, 1988)
  • 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)
  • 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)