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510(k) K061764

MEDIBYTE, MODEL MP8 by Braebon Medical Corp. — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2006
Date Received
June 22, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilatory Effort Recorder
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

Other clearances by Braebon Medical Corp.

  • 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)
  • K982216 — ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522 (September 11, 1998)
  • K981969 — ULTIMA BODY POSITION SENSOR (August 20, 1998)

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