FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01— 510(k) K862072

Name: FDA 510(k) clearance K862072
Creator: U.S. Food and Drug Administration
Published: 1986-07-09

Substantially Equivalent

International Biomedics, Inc.

FDA 510(k) clearance K862072 for FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01, Substantially Equivalent on 1986-07-09. Applicant: International Biomedics, Inc.. Device class: 2.

Clearance details

Applicant: International Biomedics, Inc.
Product code: Code HGL
Device class: Class 2
Regulation: 21 CFR 884.2960
Advisory panel: Obstetrics/Gynecology
Date received: 1986-05-30
Decision date: 1986-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bothell, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HGL

view all

K952031 — ULTRASOUND TRANSDUCER, MODEL US9171995-07-18
K923335 — ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION1994-07-22
K924516 — OP3/VP41993-06-28
K903348 — ULTRASONIC PULSED DOPPLER IMAGING SYSTEM1990-10-22
K900966 — EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE1990-09-12

More clearances from International Biomedics, Inc.

view all

K031096 — MODIFICATION TO TRANSPORT INCUBATOR 1852003-06-24
K860933 — AIR-CUSHION TOCOTONOMETER1986-07-09
K860295 — FETASCAN 15001986-05-19
K852439 — FETA SCAN 1000 OBSTETRICAL IMAGER1985-08-30

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