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510(k) K903939

PANDA HELIUM GAS ANALYZER by Medical Associated Services, Inc. — Product Code BSE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1991
Date Received
August 27, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Helium, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1640
Review Panel
AN
Submission Type

Other clearances by Medical Associated Services, Inc.

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  • K883008 — PULMONARY FORCED FLOW SYSTEM (PUFFS) (September 29, 1988)
  • K881122 — UPDATED MANUAL FOR PEDS - PULMONARY EVAL. & DIAG. (June 10, 1988)
  • K864087 — PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM (November 7, 1986)

Other clearances for product code BSE

  • K843843 — HE TEST (December 4, 1984)
  • K841858 — SPIROLOOP (July 11, 1984)