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510(k) K111934

PD-100 SERIES ULTRASONIC POCKET DOPPLER by Advanced Instrumentations, Inc. — Product Code KNG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2011
Date Received
July 8, 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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  • K141194 — FM-3000 FETAL MONITOR (November 19, 2014)
  • 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)
  • K112529 — TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER (October 27, 2011)
  • K112022 — DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (September 22, 2011)

Other clearances for product code KNG

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  • K233823 — Ultrasonic Fetal Doppler (June 28, 2024)
  • K232893 — Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fet (June 14, 2024)
  • K220245 — Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) (September 28, 2022)
  • K211940 — Fetal Doppler (January 7, 2022)
  • K212084 — Fetal Doppler (November 3, 2021)
  • K191110 — HeraBEAT™ US (November 14, 2019)
  • K182526 — Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD- (May 29, 2019)
  • K182710 — Fetal Doppler, Model FD88 (March 1, 2019)