INFRARED DELUXE— 510(k) K890586

Name: FDA 510(k) clearance K890586
Creator: U.S. Food and Drug Administration
Published: 1989-08-22

Substantially Equivalent

Healthteam

FDA 510(k) clearance K890586 for INFRARED DELUXE, Substantially Equivalent on 1989-08-22. Applicant: Healthteam. Device class: 2.

Clearance details

Applicant: Healthteam
Product code: Code ILY
Device class: Class 2
Regulation: 21 CFR 890.5500
Advisory panel: Physical Medicine
Date received: 1989-02-06
Decision date: 1989-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: S. Plainfield, NJ, US

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K890585 — INFRARED HEX1989-08-22
K890588 — GENTLE EXPRESSIONS ELECTRIC BREAST PUMP1989-05-16
K852457 — HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 81651985-12-30
K852458 — HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 81451985-12-30
K852459 — HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 81751985-12-30

Adverse events under product code ILY

product code ILY

Death: 3
Total: 3

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.