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510(k) K112529

TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER by Advanced Instrumentations, Inc. — Product Code KNG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2011
Date Received
August 31, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Ultrasonic, Fetal
Device Class
Class II
Regulation Number
884.2660
Review Panel
OB
Submission Type

Other clearances by Advanced Instrumentations, Inc.

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  • K132077 — PATIENT MONITOR (April 23, 2014)
  • K132059 — DIAGNOSTIC ULTRASOUND SYSTEM (October 25, 2013)
  • K123048 — PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO (January 11, 2013)
  • K120075 — AM-6000 ANESTHESIA MACHINE (January 26, 2012)
  • K112317 — FM-9000 PLUS FETAL AND MATERNAL MONITOR (December 21, 2011)
  • K111934 — PD-100 SERIES ULTRASONIC POCKET DOPPLER (September 22, 2011)
  • K112022 — DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (September 22, 2011)

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