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FDA 510(k)

HAKOMED ELECDT / PRO ELEDT SERIES

K-Number: K980892 · 1998-05-11

ApplicantAlive, Inc.
Decision Date1998-05-11
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HAKOMED ELECDT / PRO ELEDT SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Alive, Inc.. It received FDA 510(k) clearance on 1998-05-11 under 510(k) number K980892. 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 HAKOMED ELECDT / PRO ELEDT SERIES?

HAKOMED ELECDT / PRO ELEDT SERIES is a medical device that received FDA 510(k) clearance on 1998-05-11. The listed applicant is Alive, Inc.. The 510(k) number is K980892.

When did HAKOMED ELECDT / PRO ELEDT SERIES receive FDA 510(k) clearance?

HAKOMED ELECDT / PRO ELEDT SERIES received FDA 510(k) clearance on 1998-05-11, under 510(k) number K980892.

Who is the listed applicant for HAKOMED ELECDT / PRO ELEDT SERIES?

The FDA 510(k) record lists Alive, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HAKOMED ELECDT / PRO ELEDT SERIES?

The FDA product code for HAKOMED ELECDT / PRO ELEDT SERIES is IPF.

Related Clinical Trials

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.

Other records listing Alive, Inc. as applicant

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.

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.

Official Source

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