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FDA 510(k)

WALLABY 4

K-Number: K070180 · 2007-05-18

ApplicantRespironics Inc., Sleep & Home Respiratory Group
Decision Date2007-05-18
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

WALLABY 4 is the device name listed in this FDA 510(k) record. The listed applicant is Respironics Inc., Sleep & Home Respiratory Group. It received FDA 510(k) clearance on 2007-05-18 under 510(k) number K070180. The device is classified under product code LBI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WALLABY 4?

WALLABY 4 is a medical device that received FDA 510(k) clearance on 2007-05-18. The listed applicant is Respironics Inc., Sleep & Home Respiratory Group. The 510(k) number is K070180.

When did WALLABY 4 receive FDA 510(k) clearance?

WALLABY 4 received FDA 510(k) clearance on 2007-05-18, under 510(k) number K070180.

Who is the listed applicant for WALLABY 4?

The FDA 510(k) record lists Respironics Inc., Sleep & Home Respiratory Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WALLABY 4?

The FDA product code for WALLABY 4 is LBI.

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Other records listing Respironics Inc., Sleep & Home Respiratory Group as applicant

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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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