SPECCHIO
K-Number: K260647 · 2026-04-02
Device Summary
Frequently Asked Questions
What is the SPECCHIO?
SPECCHIO is a medical device that received FDA 510(k) clearance on 2026-04-02. The listed applicant is El.En S.P.A.. The 510(k) number is K260647.
When did SPECCHIO receive FDA 510(k) clearance?
SPECCHIO received FDA 510(k) clearance on 2026-04-02, under 510(k) number K260647.
Who is the listed applicant for SPECCHIO?
The FDA 510(k) record lists El.En S.P.A. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SPECCHIO?
The FDA product code for SPECCHIO is PBX.
Other records listing El.En S.P.A. as applicant
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.
Related Devices (Code: PBX)
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.