SCANNING DIRECTOR— 510(k) K944585

Substantially Equivalent

Prentke Romich Co.

FDA 510(k) clearance K944585 for SCANNING DIRECTOR, Substantially Equivalent on 1995-02-21. Applicant: Prentke Romich Co.. Device class: 2.

Clearance details

Applicant: Prentke Romich Co.
Product code: Code IQA
Device class: Class 2
Regulation: 21 CFR 890.3725
Advisory panel: Physical Medicine
Date received: 1994-09-19
Decision date: 1995-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wooster, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IQA

K961306 — DELTATALKER WITH INFRARED1996-06-27
K953905 — IMPERIUM1995-11-21
K953937 — LIAISON COMPUTER ACCESS & ENVIRONMENTAL CONTROL SYSTEM1995-10-31
K943244 — DEUCE1995-09-11
K944345 — BEDSIDE BUTLER1994-10-17

More clearances from Prentke Romich Co.

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