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FDA 510(k)

ELPHA 2000

K-Number: K914231 · 1992-05-28

ApplicantBiometer Intl. A/S
Decision Date1992-05-28
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ELPHA 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Biometer Intl. A/S. It received FDA 510(k) clearance on 1992-05-28 under 510(k) number K914231. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELPHA 2000?

ELPHA 2000 is a medical device that received FDA 510(k) clearance on 1992-05-28. The listed applicant is Biometer Intl. A/S. The 510(k) number is K914231.

When did ELPHA 2000 receive FDA 510(k) clearance?

ELPHA 2000 received FDA 510(k) clearance on 1992-05-28, under 510(k) number K914231.

Who is the listed applicant for ELPHA 2000?

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

What is the FDA product code for ELPHA 2000?

The FDA product code for ELPHA 2000 is IPF.

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Other records listing Biometer Intl. A/S as applicant

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Related Devices (Code: IPF)

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

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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