Autofuse
K-Number: K233572 · 2024-03-06
ApplicantPymedix
Decision Date2024-03-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Autofuse is the device name listed in this FDA 510(k) record. The listed applicant is Pymedix. It received FDA 510(k) clearance on 2024-03-06 under 510(k) number K233572. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Autofuse?
Autofuse is a medical device that received FDA 510(k) clearance on 2024-03-06. The listed applicant is Pymedix. The 510(k) number is K233572.
When did Autofuse receive FDA 510(k) clearance?
Autofuse received FDA 510(k) clearance on 2024-03-06, under 510(k) number K233572.
Who is the listed applicant for Autofuse?
The FDA 510(k) record lists Pymedix as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Autofuse?
The FDA product code for Autofuse is LLZ.
Related Devices (Code: LLZ)
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.
Official Source
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