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510(k) K771431

ARTIFICIAL K-NOSE BREATHAID by Terumo America, Inc.

K771431 is an FDA 510(k) premarket notification submitted by Terumo America, Inc. for the device "ARTIFICIAL K-NOSE BREATHAID". The FDA issued a decision of Substantially Equivalent on September 28, 1977. Terumo America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1977
Date Received
August 1, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Terumo America, Inc.

  • K811523 — PLASMA FLEX (September 9, 1981)
  • K802970 — TERUMO HOLLOW FIBER OXYGENATOR (January 22, 1981)
  • K802122 — CLIRANS TH13 HOLLOW FIBER DIALYZER (December 18, 1980)
  • K802441 — CLIRANS TH10 HOLLOW FIBER DIALYZER (December 18, 1980)
  • K801194 — CLIRANS TE07 HOLLOW FIBER DIALYZER (August 12, 1980)
  • K801192 — CLIRANS TE10 HOLLOW FIBER DIALYZER (August 12, 1980)
  • K801193 — CLIRANS TE15 HOLLOW FIBER DIALYZER (August 12, 1980)
  • K791411 — COAXIAL DUAL FLOW CATHETER (November 13, 1979)
  • K791173 — SURFLO INJECTION PLUG (July 30, 1979)
  • K790105 — TERUMO IMUGARD (May 24, 1979)

FDA data resources