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FDA 510(k)

ELECTROCYN soma

K-Number: K220286 · 2022-12-21

ApplicantV3Bio Sdn. Bhd
Decision Date2022-12-21
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

ELECTROCYN soma is the device name listed in this FDA 510(k) record. The listed applicant is V3Bio Sdn. Bhd. It received FDA 510(k) clearance on 2022-12-21 under 510(k) number K220286. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTROCYN soma?

ELECTROCYN soma is a medical device that received FDA 510(k) clearance on 2022-12-21. The listed applicant is V3Bio Sdn. Bhd. The 510(k) number is K220286.

When did ELECTROCYN soma receive FDA 510(k) clearance?

ELECTROCYN soma received FDA 510(k) clearance on 2022-12-21, under 510(k) number K220286.

Who is the listed applicant for ELECTROCYN soma?

The FDA 510(k) record lists V3Bio Sdn. Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECTROCYN soma?

The FDA product code for ELECTROCYN soma is FRO. This falls under the Anesthesiology category.

Related Devices (Code: FRO)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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