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510(k) K864087

PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM by Medical Associated Services, Inc. — Product Code BTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1986
Date Received
October 21, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Predicted Values, Pulmonary Function
Device Class
Class II
Regulation Number
868.1890
Review Panel
AN
Submission Type

Other clearances by Medical Associated Services, Inc.

  • K921178 — PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHS (August 26, 1992)
  • K903939 — PANDA HELIUM GAS ANALYZER (January 3, 1991)
  • K893845 — PEDS WATER FILLED CATHETER/TRANSDUCER SYSTEM (October 27, 1989)
  • K883008 — PULMONARY FORCED FLOW SYSTEM (PUFFS) (September 29, 1988)
  • K881122 — UPDATED MANUAL FOR PEDS - PULMONARY EVAL. & DIAG. (June 10, 1988)

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