SONORANGER TRANSVAGINAL PROBE— 510(k) K862627

Name: FDA 510(k) clearance K862627
Creator: U.S. Food and Drug Administration
Published: 1986-08-01

Substantially Equivalent for Some Indications

Ausonics Pty , Ltd.

FDA 510(k) clearance K862627 for SONORANGER TRANSVAGINAL PROBE, Substantially Equivalent for Some Indications on 1986-08-01. Applicant: Ausonics Pty , Ltd.. Device class: 2.

Clearance details

Applicant: Ausonics Pty , Ltd.
Product code: Code HEM
Device class: Class 2
Regulation: 21 CFR 884.2225
Advisory panel: Obstetrics/Gynecology
Date received: 1986-07-10
Decision date: 1986-08-01
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Suffield, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HEM

view all

K951393 — ABACUS OB ULTRASOUNG COMPUTER SOFTWARE1995-05-01
K942490 — BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND1995-02-15
K910426 — SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT1991-06-06
K905000 — ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER1991-01-31
K900505 — SONOACE 88 PORTABLE ULTRASOUND SCANNER1990-08-10

More clearances from Ausonics Pty , Ltd.

view all

K933916 — AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER1994-10-03
K915715 — CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER1992-07-02
K920307 — AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION1992-05-19
K905488 — DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN1991-12-18
K902728 — 7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815)1991-02-13

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