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510(k) K830056

ARTEC TWIST VALVE by Artec Environmental Monitoring Division — Product Code BTC

K830056 is an FDA 510(k) premarket notification submitted by Artec Environmental Monitoring Division for the device "ARTEC TWIST VALVE". The FDA issued a decision of Substantially Equivalent on March 9, 1983. The device falls under product code BTC (Bag, Reservoir), a Class I device regulated under 21 CFR 868.5320. Artec Environmental Monitoring Division has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1983
Date Received
January 6, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bag, Reservoir
Device Class
Class I
Regulation Number
868.5320
Review Panel
AN
Submission Type

Other clearances by Artec Environmental Monitoring Division

  • K900839 — THE CAROLINA ROCKER (April 18, 1990)
  • K896886 — ARTEC RESPOND PULMONARY RESUSCITATOR (February 6, 1990)
  • K873043 — MOUTH TO FACE RESUSCITATOR (September 28, 1987)
  • K863910 — RAINCOAT (October 20, 1986)
  • K854573 — ANESTHESIA SHUTOFF VALVE POSITIVE CLOSURE (January 3, 1986)
  • K832512 — AIRWAY MASKS (January 17, 1984)

Other clearances for product code BTC

  • K181424 — PeDIA (September 25, 2018)
  • K940220 — REBREATHER BAGS (May 27, 1994)
  • K932581 — BREATHING BAGS (July 16, 1993)
  • K932496 — PRECISION MED PRODUCTS, LTD. BREATHING BAGS (July 16, 1993)
  • K932584 — BREATHING BAGS (July 16, 1993)
  • K932191 — BREATHING BAGS (July 2, 1993)
  • K894906 — ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITER (September 18, 1989)
  • K880680 — KING SYSTEMS, BREATHING BAG (March 3, 1988)
  • K864822 — VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS (January 15, 1987)
  • K841411 — ROLLED NECK W/PLUG (April 18, 1984)

FDA data resources