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FDA 510(k)

Elos Accurate Hybrid Base

K-Number: K230317 · 2023-09-01

Decision Date2023-09-01
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Elos Accurate Hybrid Base is the device name listed in this FDA 510(k) record. The listed applicant is Elos Medtech Pinol A/S. It received FDA 510(k) clearance on 2023-09-01 under 510(k) number K230317. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elos Accurate Hybrid Base?

Elos Accurate Hybrid Base is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is Elos Medtech Pinol A/S. The 510(k) number is K230317.

When did Elos Accurate Hybrid Base receive FDA 510(k) clearance?

Elos Accurate Hybrid Base received FDA 510(k) clearance on 2023-09-01, under 510(k) number K230317.

Who is the listed applicant for Elos Accurate Hybrid Base?

The FDA 510(k) record lists Elos Medtech Pinol A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elos Accurate Hybrid Base?

The FDA product code for Elos Accurate Hybrid Base is NHA.

Other records listing Elos Medtech Pinol A/S 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.

View all 13 devices →

Related Devices (Code: NHA)

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.