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510(k) K001743

ULTIMA SMARTBELT, MODEL 0560 by Braebon Medical Corp. — Product Code BZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2000
Date Received
June 8, 2000
Clearance Type
Special
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 Braebon Medical Corp.

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  • K984431 — ULTIMA AIRFLOW PRESSURE SENSOR (December 30, 1998)
  • K981445 — ULTIMA AIRFLOW SENSOR, 0510 (October 5, 1998)
  • K982216 — ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522 (September 11, 1998)
  • K981969 — ULTIMA BODY POSITION SENSOR (August 20, 1998)

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