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FDA 510(k)

SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM

K-Number: K040202 · 2005-03-04

ApplicantSalter Labs
Decision Date2005-03-04
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Salter Labs. It received FDA 510(k) clearance on 2005-03-04 under 510(k) number K040202. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM?

SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM is a medical device that received FDA 510(k) clearance on 2005-03-04. The listed applicant is Salter Labs. The 510(k) number is K040202.

When did SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM receive FDA 510(k) clearance?

SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM received FDA 510(k) clearance on 2005-03-04, under 510(k) number K040202.

Who is the listed applicant for SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM?

The FDA 510(k) record lists Salter Labs as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM?

The FDA product code for SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM is BZD.

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Other records listing Salter Labs as applicant

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Related Devices (Code: BZD)

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.

K261262Altis Full Face MaskRespironics, Inc.K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.

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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