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510(k) K841858

SPIROLOOP by Datamed, Inc. — Product Code BSE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1984
Date Received
May 4, 1984
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 Datamed, Inc.

  • K904966 — DATAMED MODEL 401A TRANSRECIEVER (July 18, 1991)
  • K811419 — SPRIO-LOOP (June 12, 1981)

Other clearances for product code BSE

  • K903939 — PANDA HELIUM GAS ANALYZER (January 3, 1991)
  • K843843 — HE TEST (December 4, 1984)