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FDA 510(k)

RESPIRE BLUE SERIES

K-Number: K111207 · 2011-08-23

ApplicantRespire Medical
Decision Date2011-08-23
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RESPIRE BLUE SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Respire Medical. It received FDA 510(k) clearance on 2011-08-23 under 510(k) number K111207. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPIRE BLUE SERIES?

RESPIRE BLUE SERIES is a medical device that received FDA 510(k) clearance on 2011-08-23. The listed applicant is Respire Medical. The 510(k) number is K111207.

When did RESPIRE BLUE SERIES receive FDA 510(k) clearance?

RESPIRE BLUE SERIES received FDA 510(k) clearance on 2011-08-23, under 510(k) number K111207.

Who is the listed applicant for RESPIRE BLUE SERIES?

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

What is the FDA product code for RESPIRE BLUE SERIES?

The FDA product code for RESPIRE BLUE SERIES is LRK.

Related Clinical Trials

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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Other records listing Respire Medical as applicant

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.

K131138RESPIRE PINK SERIES - HERBST

Related Devices (Code: LRK)

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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