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FDA 510(k)

SERVOTRONIC EC100 SYSTEM

K-Number: K962087 · 1997-04-23

ApplicantMedicon, Inc.
Decision Date1997-04-23
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SERVOTRONIC EC100 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medicon, Inc.. It received FDA 510(k) clearance on 1997-04-23 under 510(k) number K962087. The device is classified under product code HWE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERVOTRONIC EC100 SYSTEM?

SERVOTRONIC EC100 SYSTEM is a medical device that received FDA 510(k) clearance on 1997-04-23. The listed applicant is Medicon, Inc.. The 510(k) number is K962087.

When did SERVOTRONIC EC100 SYSTEM receive FDA 510(k) clearance?

SERVOTRONIC EC100 SYSTEM received FDA 510(k) clearance on 1997-04-23, under 510(k) number K962087.

Who is the listed applicant for SERVOTRONIC EC100 SYSTEM?

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

What is the FDA product code for SERVOTRONIC EC100 SYSTEM?

The FDA product code for SERVOTRONIC EC100 SYSTEM is HWE.

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Other records listing Medicon, Inc. as applicant

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Related Devices (Code: HWE)

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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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