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FDA 510(k)

SLEEPSTYLE 200 AUTO SERIES HC254

K-Number: K081029 · 2008-09-12

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2008-09-12
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SLEEPSTYLE 200 AUTO SERIES HC254 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 2008-09-12 under 510(k) number K081029. 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 SLEEPSTYLE 200 AUTO SERIES HC254?

SLEEPSTYLE 200 AUTO SERIES HC254 is a medical device that received FDA 510(k) clearance on 2008-09-12. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K081029.

When did SLEEPSTYLE 200 AUTO SERIES HC254 receive FDA 510(k) clearance?

SLEEPSTYLE 200 AUTO SERIES HC254 received FDA 510(k) clearance on 2008-09-12, under 510(k) number K081029.

Who is the listed applicant for SLEEPSTYLE 200 AUTO SERIES HC254?

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 SLEEPSTYLE 200 AUTO SERIES HC254?

The FDA product code for SLEEPSTYLE 200 AUTO SERIES HC254 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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