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510(k) K201490

Electro Flo 6 Airway Clearance System by Med Systems, Inc. — Product Code BYI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2021
Date Received
June 4, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Percussor, Powered-Electric
Device Class
Class II
Regulation Number
868.5665
Review Panel
AN
Submission Type

Other clearances by Med Systems, Inc.

  • K031876 — ELECTRO FLO PERCUSSOR, MODEL 5000 (November 21, 2003)
  • K941145 — OXY-GENERATOR (September 27, 1995)
  • K853785 — SERIES 2000 MEDS MASK (December 3, 1985)

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