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510(k) K020909

HDM99 by Ibp Instruments GmbH — Product Code FIZ

K020909 is an FDA 510(k) premarket notification submitted by Ibp Instruments GmbH for the device "HDM99". The FDA issued a decision of Substantially Equivalent on May 22, 2002. The device falls under product code FIZ (Meter, Conductivity, Non-Remote), a Class II device regulated under 21 CFR 876.5820. Ibp Instruments GmbH has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2002
Date Received
March 20, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Meter, Conductivity, Non-Remote
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Ibp Instruments GmbH

  • K032075 — CONDUCTIVITY STANDARD SOLUTION-METERCARE (September 17, 2003)
  • K020908 — HDM97 (May 22, 2002)

Other clearances for product code FIZ

  • K201765 — SmartHDM-510 System (September 2, 2020)
  • K150657 — Phoenix XL Dialysate Meter (September 21, 2015)
  • K050812 — 90XL INSTRUMENTATION SYSTEM (May 5, 2005)
  • K020908 — HDM97 (May 22, 2002)
  • K992431 — NEO-2 METER (October 13, 1999)
  • K981294 — ODYSSEY INSTRUMENTATION SYSTEM (July 8, 1998)
  • K955298 — PHOENIX DIALYSATE METER (February 29, 1996)
  • K920810 — NEO-STAT DIALYSATE METER (January 15, 1993)
  • K881098 — MODIFIED NEO-I TEMPERATURE, CONDUCTIVITY METER (April 21, 1988)
  • K871708 — NEO-I TEMPERATURE & CONDUCTIVITY METER (June 17, 1987)

FDA data resources