HEAD HOLDING DEVICE/SLEEP APNEA— 510(k) K884493

Substantially Equivalent

X-Ray Systems

FDA 510(k) clearance K884493 for HEAD HOLDING DEVICE/SLEEP APNEA, Substantially Equivalent on 1989-01-12. Applicant: X-Ray Systems. Device class: 1.

Clearance details

Applicant: X-Ray Systems
Product code: Code IWY
Device class: Class 1
Regulation: 21 CFR 892.1920
Advisory panel: Radiology
Date received: 1988-10-26
Decision date: 1989-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fraser, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IWY

K925705 — ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM1992-12-28
K884847 — MTD HEDREST1989-01-09
K864527 — DUOCEPH1987-01-07
K850197 — KELLER CEPHALOMETRIC DEVICE1985-03-22
K844549 — HEAD-SPINE STABILIZER HSS-11985-03-01

More clearances from X-Ray Systems

K855161 — UPRIGHT BUCKY STAND/MOUNT1986-02-12
K855052 — TABLE RADIOGRAPHIC FIXED1986-02-06
K853682 — MOUNT TUBE RADIOGRAPHIC1985-09-19

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