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FDA 510(k)

ARTIFICIAL K-NOSE BREATHAID

K-Number: K771431 · 1977-09-28

ApplicantTerumo America, Inc.
Decision Date1977-09-28
Product Code
DecisionSubstantially Equivalent

Device Summary

ARTIFICIAL K-NOSE BREATHAID is the device name listed in this FDA 510(k) record. The listed applicant is Terumo America, Inc.. It received FDA 510(k) clearance on 1977-09-28 under 510(k) number K771431. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTIFICIAL K-NOSE BREATHAID?

ARTIFICIAL K-NOSE BREATHAID is a medical device that received FDA 510(k) clearance on 1977-09-28. The listed applicant is Terumo America, Inc.. The 510(k) number is K771431.

When did ARTIFICIAL K-NOSE BREATHAID receive FDA 510(k) clearance?

ARTIFICIAL K-NOSE BREATHAID received FDA 510(k) clearance on 1977-09-28, under 510(k) number K771431.

Who is the listed applicant for ARTIFICIAL K-NOSE BREATHAID?

The FDA 510(k) record lists Terumo America, Inc. as the applicant. This does not by itself establish the device manufacturer.

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Other records listing Terumo America, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K811523PLASMA FLEXK802970TERUMO HOLLOW FIBER OXYGENATORK802441CLIRANS TH10 HOLLOW FIBER DIALYZERK802122CLIRANS TH13 HOLLOW FIBER DIALYZERK801192CLIRANS TE10 HOLLOW FIBER DIALYZERK801193CLIRANS TE15 HOLLOW FIBER DIALYZER

View all 31 devices →

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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