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FDA 510(k)

S8 ASPEN WITH H4I PLUS

K-Number: K111148 · 2011-06-30

ApplicantResmed Corp
Decision Date2011-06-30
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

S8 ASPEN WITH H4I PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Resmed Corp. It received FDA 510(k) clearance on 2011-06-30 under 510(k) number K111148. 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 S8 ASPEN WITH H4I PLUS?

S8 ASPEN WITH H4I PLUS is a medical device that received FDA 510(k) clearance on 2011-06-30. The listed applicant is Resmed Corp. The 510(k) number is K111148.

When did S8 ASPEN WITH H4I PLUS receive FDA 510(k) clearance?

S8 ASPEN WITH H4I PLUS received FDA 510(k) clearance on 2011-06-30, under 510(k) number K111148.

Who is the listed applicant for S8 ASPEN WITH H4I PLUS?

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

What is the FDA product code for S8 ASPEN WITH H4I PLUS?

The FDA product code for S8 ASPEN WITH H4I PLUS is BZD.

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Other records listing Resmed Corp 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.

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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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