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FDA 510(k)

BABYAIR

K-Number: K060497 · 2006-07-11

ApplicantPromedic, Inc.
Decision Date2006-07-11
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BABYAIR is the device name listed in this FDA 510(k) record. The listed applicant is Promedic, Inc.. It received FDA 510(k) clearance on 2006-07-11 under 510(k) number K060497. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BABYAIR?

BABYAIR is a medical device that received FDA 510(k) clearance on 2006-07-11. The listed applicant is Promedic, Inc.. The 510(k) number is K060497.

When did BABYAIR receive FDA 510(k) clearance?

BABYAIR received FDA 510(k) clearance on 2006-07-11, under 510(k) number K060497.

Who is the listed applicant for BABYAIR?

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

What is the FDA product code for BABYAIR?

The FDA product code for BABYAIR is CAF.

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Related Devices (Code: CAF)

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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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