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FDA 510(k)

FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM

K-Number: K100011 · 2010-10-08

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2010-10-08
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM 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 2010-10-08 under 510(k) number K100011. 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 FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM?

FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM is a medical device that received FDA 510(k) clearance on 2010-10-08. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K100011.

When did FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM receive FDA 510(k) clearance?

FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM received FDA 510(k) clearance on 2010-10-08, under 510(k) number K100011.

Who is the listed applicant for FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM?

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 FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM?

The FDA product code for FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM is BZD.

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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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