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FDA 510(k)

AIR ENTRAINER 900RT008

K-Number: K953711 · 1995-11-08

ApplicantFisher & Paykel Electronics , Ltd.
Decision Date1995-11-08
Product CodeBZR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AIR ENTRAINER 900RT008 is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Electronics , Ltd.. It received FDA 510(k) clearance on 1995-11-08 under 510(k) number K953711. The device is classified under product code BZR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIR ENTRAINER 900RT008?

AIR ENTRAINER 900RT008 is a medical device that received FDA 510(k) clearance on 1995-11-08. The listed applicant is Fisher & Paykel Electronics , Ltd.. The 510(k) number is K953711.

When did AIR ENTRAINER 900RT008 receive FDA 510(k) clearance?

AIR ENTRAINER 900RT008 received FDA 510(k) clearance on 1995-11-08, under 510(k) number K953711.

Who is the listed applicant for AIR ENTRAINER 900RT008?

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

What is the FDA product code for AIR ENTRAINER 900RT008?

The FDA product code for AIR ENTRAINER 900RT008 is BZR.

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Other records listing Fisher & Paykel Electronics , Ltd. as applicant

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Related Devices (Code: BZR)

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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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