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510(k) K861743

AS165 RESPIRATION MONITOR by Air-Shields, Inc. — Product Code BZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1986
Date Received
May 6, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Breathing Frequency
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

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  • K924170 — ISOLETTE INCUBATOR HUMIDITY METER (February 5, 1993)
  • K922150 — EXAMINATION LAMP (July 21, 1992)

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