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510(k) K982216

ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522 by Braebon Medical Corp. — Product Code BZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1998
Date Received
June 23, 1998
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 Braebon Medical Corp.

  • K061764 — MEDIBYTE, MODEL MP8 (September 6, 2006)
  • K031202 — MEDIPALM-20 (May 1, 2003)
  • K020312 — ULTIMA SNORING MIKE, MODEL 0540 (August 7, 2002)
  • K001743 — ULTIMA SMARTBELT, MODEL 0560 (August 25, 2000)
  • K984431 — ULTIMA AIRFLOW PRESSURE SENSOR (December 30, 1998)
  • K981445 — ULTIMA AIRFLOW SENSOR, 0510 (October 5, 1998)
  • K981969 — ULTIMA BODY POSITION SENSOR (August 20, 1998)

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