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FDA 510(k)

VICARDIO 12B

K-Number: K082380 · 2008-12-03

ApplicantEnergy-Lab Technologies GmbH
Decision Date2008-12-03
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VICARDIO 12B is the device name listed in this FDA 510(k) record. The listed applicant is Energy-Lab Technologies GmbH. It received FDA 510(k) clearance on 2008-12-03 under 510(k) number K082380. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VICARDIO 12B?

VICARDIO 12B is a medical device that received FDA 510(k) clearance on 2008-12-03. The listed applicant is Energy-Lab Technologies GmbH. The 510(k) number is K082380.

When did VICARDIO 12B receive FDA 510(k) clearance?

VICARDIO 12B received FDA 510(k) clearance on 2008-12-03, under 510(k) number K082380.

Who is the listed applicant for VICARDIO 12B?

The FDA 510(k) record lists Energy-Lab Technologies GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VICARDIO 12B?

The FDA product code for VICARDIO 12B is DPS.

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Related Devices (Code: DPS)

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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