FDA 510(k)

EDI 320

K-Number: K873599 · 1987-10-16

ApplicantCybex

Decision Date1987-10-16

Product CodeKQX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

EDI 320 is the device name listed in this FDA 510(k) record. The listed applicant is Cybex. It received FDA 510(k) clearance on 1987-10-16 under 510(k) number K873599. The device is classified under product code KQX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDI 320?

EDI 320 is a medical device that received FDA 510(k) clearance on 1987-10-16. The listed applicant is Cybex. The 510(k) number is K873599.

When did EDI 320 receive FDA 510(k) clearance?

EDI 320 received FDA 510(k) clearance on 1987-10-16, under 510(k) number K873599.

Who is the listed applicant for EDI 320?

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

What is the FDA product code for EDI 320?

The FDA product code for EDI 320 is KQX.

Other records listing Cybex 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.

K950095CYBEX 770 K905525CYBEX 6000 K881676LINEAR LIFT DEVICE K881681CYBEX BACK TESTING AND REHABILITATION SYSTEM K894154METABOLIC SYSTEMS K872911CYBEX 340

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Related Devices (Code: KQX)

K011827ORTELIUS 800Orthoscan , Ltd.K971079INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWAREInterlogics, Inc.K9623773D-SPINESkill Technologies, Inc.K961212SPINAL TOUCHFasstech K954647INCLINOMETERJ-Tech, Inc.K943929DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS)Greenleaf Medical Systems, Inc.

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.