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510(k) K875334

KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM by Kontron Instruments, Inc. — Product Code HGL

K875334 is an FDA 510(k) premarket notification submitted by Kontron Instruments, Inc. for the device "KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM". The FDA issued a decision of Substantially Equivalent on March 24, 1988. The device falls under product code HGL (Transducer, Ultrasonic, Obstetric), a Class II device regulated under 21 CFR 884.2960. Kontron Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1988
Date Received
December 30, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Obstetric
Device Class
Class II
Regulation Number
884.2960
Review Panel
OB
Submission Type

Other clearances by Kontron Instruments, Inc.

  • K971038 — KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE (September 24, 1997)
  • K932268 — MODIFICATIONS TO INTRA-AORTIC BALLOONS (December 15, 1993)
  • K925248 — MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS (September 27, 1993)
  • K923603 — INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION (March 8, 1993)
  • K905313 — KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II (June 19, 1991)
  • K903344 — 9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM) (January 15, 1991)
  • K896437 — KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM (December 3, 1990)
  • K892222 — 9.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOON (September 14, 1990)
  • K882955 — SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283 (January 26, 1990)
  • K896386 — MINIMON 7133B PATIENT MONITOR (December 13, 1989)

Other clearances for product code HGL

  • K952031 — ULTRASOUND TRANSDUCER, MODEL US917 (July 18, 1995)
  • K923335 — ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION (July 22, 1994)
  • K924516 — OP3/VP4 (June 28, 1993)
  • K903348 — ULTRASONIC PULSED DOPPLER IMAGING SYSTEM (October 22, 1990)
  • K900966 — EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE (September 12, 1990)
  • K903316 — ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER (August 22, 1990)
  • K901142 — MER MULTIPLANE VAGINAL PROBE (MVP) (August 22, 1990)
  • K900838 — TRANSVAGINAL TRANSDUCER ASSEMBLY (May 23, 1990)
  • K895449 — ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM (March 5, 1990)
  • K881263 — MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER (January 5, 1990)

FDA data resources