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510(k) K113053

BIPAP A 30 VENTILATORY SUPPORT SYSTEM by Respironics, Inc. — Product Code MNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2012
Date Received
October 13, 2011
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Non-Life-Supporting
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

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Other clearances for product code MNS

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  • K161487 — VPAP Adapt SV, VPAP Tx, S9 VPAP Tx (September 9, 2016)
  • K153061 — Juno VPAP ST-A (April 13, 2016)
  • K132371 — EASYCARE ONLINE (November 22, 2013)
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