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FDA 510(k)

RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS

K-Number: K034026 · 2005-01-12

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2005-01-12
Product CodeBZE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2005-01-12 under 510(k) number K034026. The device is classified under product code BZE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS?

RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS is a medical device that received FDA 510(k) clearance on 2005-01-12. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K034026.

When did RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS receive FDA 510(k) clearance?

RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS received FDA 510(k) clearance on 2005-01-12, under 510(k) number K034026.

Who is the listed applicant for RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS?

The FDA 510(k) record lists Fisher & Paykel Healthcare, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS?

The FDA product code for RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS is BZE.

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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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