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FDA 510(k)

Twoplus Applicator

K-Number: K232579 · 2023-12-21

ApplicantHannah Life Technologies Pte , Ltd.
Decision Date2023-12-21
Product CodeQYZ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Twoplus Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Hannah Life Technologies Pte , Ltd.. It received FDA 510(k) clearance on 2023-12-21 under 510(k) number K232579. The device is classified under product code QYZ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Twoplus Applicator?

Twoplus Applicator is a medical device that received FDA 510(k) clearance on 2023-12-21. The listed applicant is Hannah Life Technologies Pte , Ltd.. The 510(k) number is K232579.

When did Twoplus Applicator receive FDA 510(k) clearance?

Twoplus Applicator received FDA 510(k) clearance on 2023-12-21, under 510(k) number K232579.

Who is the listed applicant for Twoplus Applicator?

The FDA 510(k) record lists Hannah Life Technologies Pte , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Twoplus Applicator?

The FDA product code for Twoplus Applicator is QYZ.

Related Devices (Code: QYZ)

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.

K231645PherDal® At-Home Insemination KitPherdal Fertility Science, Inc.K231203Mosie Baby KitMosie Baby

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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