ROTARY COMMUNICATION SCANNER MODEL 7010— 510(k) K901030

Name: FDA 510(k) clearance K901030
Creator: U.S. Food and Drug Administration
Published: 1990-03-13

Substantially Equivalent

Baylor Biomedical Services

FDA 510(k) clearance K901030 for ROTARY COMMUNICATION SCANNER MODEL 7010, Substantially Equivalent on 1990-03-13. Applicant: Baylor Biomedical Services. Device class: 2.

Clearance details

Applicant: Baylor Biomedical Services
Product code: Code ILQ
Device class: Class 2
Regulation: 21 CFR 890.3710
Advisory panel: Physical Medicine
Date received: 1990-03-06
Decision date: 1990-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ILQ

view all

K162817 — Noddle(TM)2017-01-18
K943035 — P.A.T. SYSTEM1994-10-04
K930044 — COMFORT KEYBOARD SYSTEM1994-07-14
K931855 — LIGHTWRITER1994-05-10
K935244 — R & D BATTERIES, INC. PART NUMBER 51131994-04-19

More clearances from Baylor Biomedical Services

view all

K900969 — REMOTE CONTROL SWITCH1990-03-13
K901028 — ENVIRONMENTAL CONTROL UNIT MODEL 70001990-03-13
K901029 — YES-NO VOICE BOX 70111990-03-13

Adverse events under product code ILQ

product code ILQ

Death: 4
Malfunction: 477
Total: 481

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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