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510(k) K912336

ARTEMA AQUA+ FLEX by Artema Medical AB — Product Code BYD

K912336 is an FDA 510(k) premarket notification submitted by Artema Medical AB for the device "ARTEMA AQUA+ FLEX". The FDA issued a decision of Substantially Equivalent on July 26, 1991. The device falls under product code BYD (Condenser, Heat And Moisture (Artificial Nose)), a Class I device regulated under 21 CFR 868.5375. Artema Medical AB has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1991
Date Received
May 24, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condenser, Heat And Moisture (Artificial Nose)
Device Class
Class I
Regulation Number
868.5375
Review Panel
AN
Submission Type

Other clearances by Artema Medical AB

  • K945359 — AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H (February 21, 1995)
  • K912334 — ARTEMA AQUA+ T & TS (July 26, 1991)
  • K912333 — ARTEMA AQUA+ (July 26, 1991)
  • K912335 — ARTEMA AQUA+ N (July 26, 1991)

Other clearances for product code BYD

  • K955008 — HEAT & MOISTURE EXCHANGER (January 30, 1996)
  • K954194 — DISPOSABLE HME/FILTER (October 20, 1995)
  • K953580 — HEAT MOISTURE EXCHANGER (September 15, 1995)
  • K953507 — TYPE 1 & 2 (HUMIDAIR I & II) (September 7, 1995)
  • K953544 — HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT (August 25, 1995)
  • K953540 — EEE (August 25, 1995)
  • K953620 — WARM N WET HMEF W/LUER ADAPTER (August 25, 1995)
  • K953491 — HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE (August 25, 1995)
  • K953619 — WARM N WET HME W/LUER ADAPTER (August 25, 1995)
  • K952845 — HUMID-VENT TRACH-VENT (July 25, 1995)

FDA data resources