Decision Date2024-09-17
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Robin's Egg is the device name listed in this FDA 510(k) record. The listed applicant is Telebrands Corporation. It received FDA 510(k) clearance on 2024-09-17 under 510(k) number K240689. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Robin's Egg?
Robin's Egg is a medical device that received FDA 510(k) clearance on 2024-09-17. The listed applicant is Telebrands Corporation. The 510(k) number is K240689.
When did Robin's Egg receive FDA 510(k) clearance?
Robin's Egg received FDA 510(k) clearance on 2024-09-17, under 510(k) number K240689.
Who is the listed applicant for Robin's Egg?
The FDA 510(k) record lists Telebrands Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Robin's Egg?
The FDA product code for Robin's Egg is OAP.
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Official Source
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