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FDA 510(k)

EDGE

K-Number: K941996 · 1994-08-25

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date1994-08-25
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EDGE is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 1994-08-25 under 510(k) number K941996. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDGE?

EDGE is a medical device that received FDA 510(k) clearance on 1994-08-25. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K941996.

When did EDGE receive FDA 510(k) clearance?

EDGE received FDA 510(k) clearance on 1994-08-25, under 510(k) number K941996.

Who is the listed applicant for EDGE?

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

What is the FDA product code for EDGE?

The FDA product code for EDGE is LNH.

Related PubMed Literature

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.

PMID: 40854178Health Professional Students' Knowledge About FDA Drug and Medical Device Regulation.Academic medicine : journal of the Association of American Medical Colleges ()

Other records listing Philips Medical Systems (Cleveland), Inc. as applicant

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Related Devices (Code: LNH)

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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