DISPOSABLE NEONATAL VENTILATION CIRCUIT— 510(k) K813384

Substantially Equivalent

Intec.

FDA 510(k) clearance K813384 for DISPOSABLE NEONATAL VENTILATION CIRCUIT, Substantially Equivalent on 1982-01-07. Applicant: Intec.. Device class: 1.

Clearance details

Applicant: Intec.
Product code: Code BZO
Device class: Class 1
Regulation: 21 CFR 868.5975
Advisory panel: Anesthesiology
Date received: 1981-12-02
Decision date: 1982-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blue Springs, MO, 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 Intec.

K813382 — DISPOSABLE ADULT ANES. CIRCUIT1982-01-22
K813383 — DISPOSABLE TRACH SWIVEL CONNECTOR1981-12-31

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