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510(k) K904396

SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM by Simplex Medical Systems, Inc. — Product Code BZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1991
Date Received
September 25, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Breathing Frequency
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

Other clearances by Simplex Medical Systems, Inc.

  • K970249 — SIMPLEX AIRBRATOR (May 7, 1997)
  • K932288 — NEONATAL BREATHING CIRCUIT MODIFICATION (December 30, 1994)

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