510(k) K031202

MEDIPALM-20 by Braebon Medical Corp. — Product Code OLV

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 1, 2003
Date Received: April 16, 2003
Clearance Type: Traditional
Expedited Review: No
Third Party Review: Yes

Device Classification

Device Name: Standard Polysomnograph With Electroencephalograph
Device Class: Class II
Regulation Number: 882.1400
Review Panel: NE
Submission Type

Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.

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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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