Decision Date2024-12-19
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) is the device name listed in this FDA 510(k) record. The listed applicant is Joytech Healthcare Co. , Ltd.. It received FDA 510(k) clearance on 2024-12-19 under 510(k) number K241322. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)?
Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) is a medical device that received FDA 510(k) clearance on 2024-12-19. The listed applicant is Joytech Healthcare Co. , Ltd.. The 510(k) number is K241322.
When did Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) receive FDA 510(k) clearance?
Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) received FDA 510(k) clearance on 2024-12-19, under 510(k) number K241322.
Who is the listed applicant for Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)?
The FDA 510(k) record lists Joytech Healthcare Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)?
The FDA product code for Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) is HGX.
Other records listing Joytech Healthcare Co. , Ltd. as applicant
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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.