510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K905536Substantially Equivalent

Fetal Doppler

Toshiba America Medical Systems, In.C, Tustin CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905536 is the FDA 510(k) clearance record for FETAL DOPPLER, a class II device, cleared for Toshiba America Medical Systems, In.C on under FDA product code MAA (Monitor, Fetal Doppler Ultrasound). FDA records list 146 510(k) clearances for Toshiba America Medical Systems, In.C, from to . As of , FDA records show no recalls naming K905536.

Clearance record

Decision date
Received
(497 days to decision)
Product code
MAA Monitor, Fetal Doppler Ultrasound
Regulation
21 CFR 884.2660
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Toshiba America Medical Systems, In.C 2441 Michelle Dr., Tustin CA
Third party review
No

Clearances, product code MAA

Trailing 12 months

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

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