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510(k) K980551

SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM by Nidek Medical Products, Inc. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 1998
Date Received
February 12, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Non-Continuous (Respirator)
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

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  • K942593 — OXYCHEK OXYGEN ANALYZER (May 3, 1995)

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