510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020908Substantially Equivalent

Hdm97

Ibp Instruments GmbH, Hannover, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020908 is the FDA 510(k) clearance record for HDM97, a class II device, cleared for Ibp Instruments GmbH on under FDA product code FIZ (Meter, Conductivity, Non-Remote). FDA records list 3 510(k) clearances for Ibp Instruments GmbH, from to . As of , FDA records show no recalls naming K020908.

Clearance record

Decision date
Received
(63 days to decision)
Product code
FIZ Meter, Conductivity, Non-Remote
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Ibp Instruments GmbH Sutelstr. 7a, Hannover, DE
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code FIZ

Trailing 12 months

FDA records hold no clearances under product code FIZ in the trailing twelve months.

FDA records show no clearances under product code FIZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FIZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260