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510(k) K052335

ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA by Accutron, Inc. — Product Code BSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2005
Date Received
August 26, 2005
Clearance Type
Traditional
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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  • K992421 — GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076 (October 27, 1999)
  • 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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