510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K870606Substantially Equivalent

Tonomitor(tm)

Tonometrics Holdings SA C/O Mackeen Consultants, Bethesda MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870606 is the FDA 510(k) clearance record for TONOMITOR(TM), a class I device, cleared for Tonometrics Holdings SA C/O Mackeen Consultants on under FDA product code FFT (Electrode, Ph, Stomach). FDA records list one 510(k) clearance for Tonometrics Holdings SA C/O Mackeen Consultants. As of , FDA records show no recalls naming K870606.

Clearance record

Decision date
Received
(58 days to decision)
Product code
FFT Electrode, Ph, Stomach
Regulation
21 CFR 876.1400
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Tonometrics Holdings SA C/O Mackeen Consultants 4903 Sangamore Rd., Bethesda MD
Third party review
No

Clearances, product code FFT

Trailing 12 months

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

FDA records show no clearances under product code FFT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FFT, 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