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FDA 510(k)

EMED-F-SYSTEM

K-Number: K871690 · 1987-05-15

ApplicantNovel GmbH
Decision Date1987-05-15
Product CodeIKE
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

EMED-F-SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Novel GmbH. It received FDA 510(k) clearance on 1987-05-15 under 510(k) number K871690. The device is classified under product code IKE. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMED-F-SYSTEM?

EMED-F-SYSTEM is a medical device that received FDA 510(k) clearance on 1987-05-15. The listed applicant is Novel GmbH. The 510(k) number is K871690.

When did EMED-F-SYSTEM receive FDA 510(k) clearance?

EMED-F-SYSTEM received FDA 510(k) clearance on 1987-05-15, under 510(k) number K871690.

Who is the listed applicant for EMED-F-SYSTEM?

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

What is the FDA product code for EMED-F-SYSTEM?

The FDA product code for EMED-F-SYSTEM is IKE.

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Related Devices (Code: IKE)

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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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