ENVIRONMENTAL CONTROL UNIT MODEL 7000— 510(k) K901028

Name: FDA 510(k) clearance K901028
Creator: U.S. Food and Drug Administration
Published: 1990-03-13

Substantially Equivalent

Baylor Biomedical Services

FDA 510(k) clearance K901028 for ENVIRONMENTAL CONTROL UNIT MODEL 7000, Substantially Equivalent on 1990-03-13. Applicant: Baylor Biomedical Services. Device class: 2.

Clearance details

Applicant: Baylor Biomedical Services
Product code: Code IQA
Device class: Class 2
Regulation: 21 CFR 890.3725
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 IQA

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K961306 — DELTATALKER WITH INFRARED1996-06-27
K953905 — IMPERIUM1995-11-21
K953937 — LIAISON COMPUTER ACCESS & ENVIRONMENTAL CONTROL SYSTEM1995-10-31
K943244 — DEUCE1995-09-11
K944585 — SCANNING DIRECTOR1995-02-21

More clearances from Baylor Biomedical Services

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K900969 — REMOTE CONTROL SWITCH1990-03-13
K901029 — YES-NO VOICE BOX 70111990-03-13
K901030 — ROTARY COMMUNICATION SCANNER MODEL 70101990-03-13

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