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510(k) K992421

GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076 by Accutron, Inc. — Product Code BSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1999
Date Received
July 21, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas-Machine, Anesthesia
Device Class
Class II
Regulation Number
868.5160
Review Panel
AN
Submission Type

Other clearances by Accutron, Inc.

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  • K965239 — PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING (March 28, 1997)
  • K970046 — UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550) (March 28, 1997)

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