TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC SYSTEM— 510(k) K892342

Name: FDA 510(k) clearance K892342
Creator: U.S. Food and Drug Administration
Published: 1989-11-17

Substantially Equivalent

Bay Shore Medical Equipment Corp.

FDA 510(k) clearance K892342 for TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC SYSTEM, Substantially Equivalent on 1989-11-17. Applicant: Bay Shore Medical Equipment Corp.. Device class: 2.

Clearance details

Applicant: Bay Shore Medical Equipment Corp.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 1989-04-05
Decision date: 1989-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bay Shore, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IZH

view all

K203509 — SMART FINDER2021-07-14
K202294 — Affirm Contrast Biopsy2020-10-05
K191495 — Biopsy Positioner2019-07-03
K161575 — Affirm Lateral Arm Upright Biopsy Accessory2016-08-10
K161920 — Comfort Cover2016-07-15

More clearances from Bay Shore Medical Equipment Corp.

view all

K922814 — TEC1410 ANATOMICAL PROGRAMMING GENERATOR-MODIFICAT1992-09-11
K904397 — TEC 14101990-11-13

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