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510(k) K971501

SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER by Bio-Logic Systems Corp. — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1997
Date Received
April 24, 1997
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

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  • K021895 — BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM (July 1, 2002)
  • K021801 — BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS (June 27, 2002)

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