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FDA 510(k)

PEACH 2, PEACH 2 Duo, PEACH 2 go

K-Number: K231977 · 2023-09-25

ApplicantForeo, Inc.
Decision Date2023-09-25
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PEACH 2, PEACH 2 Duo, PEACH 2 go is the device name listed in this FDA 510(k) record. The listed applicant is Foreo, Inc.. It received FDA 510(k) clearance on 2023-09-25 under 510(k) number K231977. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEACH 2, PEACH 2 Duo, PEACH 2 go?

PEACH 2, PEACH 2 Duo, PEACH 2 go is a medical device that received FDA 510(k) clearance on 2023-09-25. The listed applicant is Foreo, Inc.. The 510(k) number is K231977.

When did PEACH 2, PEACH 2 Duo, PEACH 2 go receive FDA 510(k) clearance?

PEACH 2, PEACH 2 Duo, PEACH 2 go received FDA 510(k) clearance on 2023-09-25, under 510(k) number K231977.

Who is the listed applicant for PEACH 2, PEACH 2 Duo, PEACH 2 go?

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

What is the FDA product code for PEACH 2, PEACH 2 Duo, PEACH 2 go?

The FDA product code for PEACH 2, PEACH 2 Duo, PEACH 2 go is OHT.

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Official Source

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