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FDA 510(k)

DEFI 2

K-Number: K851931 · 1985-08-05

ApplicantS & W Medico Teknik
Decision Date1985-08-05
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DEFI 2 is the device name listed in this FDA 510(k) record. The listed applicant is S & W Medico Teknik. It received FDA 510(k) clearance on 1985-08-05 under 510(k) number K851931. 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 DEFI 2?

DEFI 2 is a medical device that received FDA 510(k) clearance on 1985-08-05. The listed applicant is S & W Medico Teknik. The 510(k) number is K851931.

When did DEFI 2 receive FDA 510(k) clearance?

DEFI 2 received FDA 510(k) clearance on 1985-08-05, under 510(k) number K851931.

Who is the listed applicant for DEFI 2?

The FDA 510(k) record lists S & W Medico Teknik as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEFI 2?

The FDA product code for DEFI 2 is LDD.

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Related Devices (Code: LDD)

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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.

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