UNI-SET— 510(k) K820128

Substantially Equivalent

Inhalation Therapy Equipment, Co.

FDA 510(k) clearance K820128 for UNI-SET, Substantially Equivalent on 1982-03-23. Applicant: Inhalation Therapy Equipment, Co.. Device class: 1.

Clearance details

Applicant: Inhalation Therapy Equipment, Co.
Product code: Code BZO
Device class: Class 1
Regulation: 21 CFR 868.5975
Advisory panel: Anesthesiology
Date received: 1982-01-18
Decision date: 1982-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BZO

K953784 — UNICOR, INC. CORRUGATED TUBING1995-09-19
K953785 — UNICOR, INC. VENTILATOR HOSES1995-09-18
K952010 — PRIMA VENTILATOR HOSES1995-05-22
K952011 — PRIMA BREATHING BAGS1995-05-22
K952012 — PRIMA CUSTOM ANESTESIA CIRCUIT1995-05-22

More clearances from Inhalation Therapy Equipment, Co.

K821191 — STER-O-MIST 1000 ML1982-05-13
K820227 — STER-O-DOSE1982-02-23

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