FDA 510(k)

BABY FACE

K-Number: K994385 · 2000-03-16

Decision Date2000-03-16

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BABY FACE is the device name listed in this FDA 510(k) record. The listed applicant is Sonora Medical Systems. It received FDA 510(k) clearance on 2000-03-16 under 510(k) number K994385. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BABY FACE?

BABY FACE is a medical device that received FDA 510(k) clearance on 2000-03-16. The listed applicant is Sonora Medical Systems. The 510(k) number is K994385.

When did BABY FACE receive FDA 510(k) clearance?

BABY FACE received FDA 510(k) clearance on 2000-03-16, under 510(k) number K994385.

Who is the listed applicant for BABY FACE?

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

What is the FDA product code for BABY FACE?

The FDA product code for BABY FACE is IYO.

Other records listing Sonora Medical Systems 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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.