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FDA 510(k)

PRIMEDIC DEFIBRILLATORS-N/B

K-Number: K921765 · 1993-03-03

ApplicantMetronic Electronic GmbH
Decision Date1993-03-03
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRIMEDIC DEFIBRILLATORS-N/B is the device name listed in this FDA 510(k) record. The listed applicant is Metronic Electronic GmbH. It received FDA 510(k) clearance on 1993-03-03 under 510(k) number K921765. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIMEDIC DEFIBRILLATORS-N/B?

PRIMEDIC DEFIBRILLATORS-N/B is a medical device that received FDA 510(k) clearance on 1993-03-03. The listed applicant is Metronic Electronic GmbH. The 510(k) number is K921765.

When did PRIMEDIC DEFIBRILLATORS-N/B receive FDA 510(k) clearance?

PRIMEDIC DEFIBRILLATORS-N/B received FDA 510(k) clearance on 1993-03-03, under 510(k) number K921765.

Who is the listed applicant for PRIMEDIC DEFIBRILLATORS-N/B?

The FDA 510(k) record lists Metronic Electronic GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRIMEDIC DEFIBRILLATORS-N/B?

The FDA product code for PRIMEDIC DEFIBRILLATORS-N/B is LDD.

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Related Devices (Code: LDD)

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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