EEE— 510(k) K953540

Substantially Equivalent

Edentec Corp.

FDA 510(k) clearance K953540 for EEE, Substantially Equivalent on 1995-08-25. Applicant: Edentec Corp.. Device class: 1.

Clearance details

Applicant: Edentec Corp.
Product code: Code BYD
Device class: Class 1
Regulation: 21 CFR 868.5375
Advisory panel: Anesthesiology
Date received: 1995-07-28
Decision date: 1995-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BYD

K955008 — HEAT & MOISTURE EXCHANGER1996-01-30
K954194 — DISPOSABLE HME/FILTER1995-10-20
K953580 — HEAT MOISTURE EXCHANGER1995-09-15
K953507 — TYPE 1 & 2 (HUMIDAIR I & II)1995-09-07
K953491 — HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE1995-08-25

More clearances from Edentec Corp.

K953363 — OXIFLOW DIGITAL RECORDER1996-02-06
K921819 — EDENTEC MODEL 3710 I DIGITAL PRINTER1993-10-22
K913749 — EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 31701992-07-02
K910870 — EDENTEC MODEL 3711 DIGITAL RECORDER1991-08-29
K910871 — EDENTEC DIGITAL CHARTER MODEL 37101991-08-29

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