ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER— 510(k) K905000

Name: FDA 510(k) clearance K905000
Creator: U.S. Food and Drug Administration
Published: 1991-01-31

Substantially Equivalent

Corometrics Medical Systems, Inc.

FDA 510(k) clearance K905000 for ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER, Substantially Equivalent on 1991-01-31. Applicant: Corometrics Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Corometrics Medical Systems, Inc.
Product code: Code HEM
Device class: Class 2
Regulation: 21 CFR 884.2225
Advisory panel: Obstetrics/Gynecology
Date received: 1990-11-07
Decision date: 1991-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallingford, 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
K900505 — SONOACE 88 PORTABLE ULTRASOUND SCANNER1990-08-10
K900271 — MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK1990-04-19

More clearances from Corometrics Medical Systems, Inc.

view all

K982651 — COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER1998-12-11
K903623 — MODEL600 UTERINE ACTIVITY MONITOR1990-11-07
K891997 — CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER1989-06-08
K880900 — SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER1988-06-01

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