Cleared Traditional

K905536 - FETAL DOPPLER
(FDA 510(k) Clearance)

K905536 · Toshiba America Medical Systems, In.C · Radiology
Apr 1992
Decision
497d
Days
Class 2
Risk

K905536 is an FDA 510(k) clearance for the FETAL DOPPLER, a Monitor, Fetal Doppler Ultrasound (Class II — Special Controls, product code MAA), submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on April 21, 1992, 497 days after receiving the submission on December 11, 1990. This device falls under the Radiology review panel. Regulated under 21 CFR 884.2660.

Submission Details

510(k) Number K905536 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 1990
Decision Date April 21, 1992
Days to Decision 497 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

Product Code MAA — Monitor, Fetal Doppler Ultrasound
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.2660