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510(k) K852515

ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR by Alternative Design Systems, Inc. — Product Code BZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1985
Date Received
June 13, 1985
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 Alternative Design Systems, Inc.

  • K874719 — STRATUM ESU (February 16, 1988)
  • K874697 — STRATUM D (December 15, 1987)
  • K854757 — 5000 SERIES ECG ELECTRODES (April 23, 1986)
  • K853633 — TENS CONDUCTIVE MEDIA PAD (December 3, 1985)
  • K830778 — MONITORING KIT AMK-1 (October 14, 1983)

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