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510(k) K843355

TRANSDUCER FOR KONTROL 5MHZ SIGMA 20 by Kontron Instruments, Inc. — Product Code MHZ

K843355 is an FDA 510(k) premarket notification submitted by Kontron Instruments, Inc. for the device "TRANSDUCER FOR KONTROL 5MHZ SIGMA 20". The FDA issued a decision of Substantially Equivalent on December 3, 1984. The device falls under product code MHZ (Stimulator, Vestibular Acceleration, Therapeutic), a Class III device. Kontron Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1984
Date Received
August 27, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Vestibular Acceleration, Therapeutic
Device Class
Class III
Regulation Number
Review Panel
NE
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)

FDA data resources