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FDA 510(k)

MAGNE-FIELD 400D OSTEO-BIO-NETIC SYS

K-Number: K820995 · 1982-05-25

ApplicantLudek Optics, Inc.
Decision Date1982-05-25
Product CodeKRO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MAGNE-FIELD 400D OSTEO-BIO-NETIC SYS is the device name listed in this FDA 510(k) record. The listed applicant is Ludek Optics, Inc.. It received FDA 510(k) clearance on 1982-05-25 under 510(k) number K820995. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGNE-FIELD 400D OSTEO-BIO-NETIC SYS?

MAGNE-FIELD 400D OSTEO-BIO-NETIC SYS is a medical device that received FDA 510(k) clearance on 1982-05-25. The listed applicant is Ludek Optics, Inc.. The 510(k) number is K820995.

When did MAGNE-FIELD 400D OSTEO-BIO-NETIC SYS receive FDA 510(k) clearance?

MAGNE-FIELD 400D OSTEO-BIO-NETIC SYS received FDA 510(k) clearance on 1982-05-25, under 510(k) number K820995.

Who is the listed applicant for MAGNE-FIELD 400D OSTEO-BIO-NETIC SYS?

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

What is the FDA product code for MAGNE-FIELD 400D OSTEO-BIO-NETIC SYS?

The FDA product code for MAGNE-FIELD 400D OSTEO-BIO-NETIC SYS is KRO.

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Related Devices (Code: KRO)

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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