DOPPLER (UTD-5 & UTD-6)— 510(k) K771211

Substantially Equivalent

Terumo America, Inc.

FDA 510(k) clearance K771211 for DOPPLER (UTD-5 & UTD-6), Substantially Equivalent on 1977-07-14. Applicant: Terumo America, Inc.. Device class: 2.

Clearance details

Applicant: Terumo America, Inc.
Product code: Code HEK
Device class: Class 2
Regulation: 21 CFR 884.2660
Advisory panel: Obstetrics/Gynecology
Date received: 1977-07-05
Decision date: 1977-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HEK

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K060410 — ECHOHEART TRANSVAGINAL DOPPLER PROBE2006-04-10
K902190 — FETAL PULSE DETECTOR MODEL DOP-11990-10-22
K883334 — BIODOP(TM)1988-12-15

More clearances from Terumo America, Inc.

K811523 — PLASMA FLEX1981-09-09
K802970 — TERUMO HOLLOW FIBER OXYGENATOR1981-01-22
K802122 — CLIRANS TH13 HOLLOW FIBER DIALYZER1980-12-18
K802441 — CLIRANS TH10 HOLLOW FIBER DIALYZER1980-12-18
K801192 — CLIRANS TE10 HOLLOW FIBER DIALYZER1980-08-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.