ARTEMA AQUA+ T & TS— 510(k) K912334

Substantially Equivalent

Artema Medical AB

FDA 510(k) clearance K912334 for ARTEMA AQUA+ T & TS, Substantially Equivalent on 1991-07-26. Applicant: Artema Medical AB. Device class: 1.

Clearance details

Applicant: Artema Medical AB
Product code: Code BYD
Device class: Class 1
Regulation: 21 CFR 868.5375
Advisory panel: Anesthesiology
Date received: 1991-05-24
Decision date: 1991-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sweden, SE

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 Artema Medical AB

K945359 — AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H1995-02-21
K912333 — ARTEMA AQUA+1991-07-26
K912335 — ARTEMA AQUA+ N1991-07-26
K912336 — ARTEMA AQUA+ FLEX1991-07-26

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