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FDA 510(k)

SENSIMATIC 500SE

K-Number: K950239 · 1995-06-06

ApplicantParkell, Inc.
Decision Date1995-06-06
Product CodeEKZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SENSIMATIC 500SE is the device name listed in this FDA 510(k) record. The listed applicant is Parkell, Inc.. It received FDA 510(k) clearance on 1995-06-06 under 510(k) number K950239. The device is classified under product code EKZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENSIMATIC 500SE?

SENSIMATIC 500SE is a medical device that received FDA 510(k) clearance on 1995-06-06. The listed applicant is Parkell, Inc.. The 510(k) number is K950239.

When did SENSIMATIC 500SE receive FDA 510(k) clearance?

SENSIMATIC 500SE received FDA 510(k) clearance on 1995-06-06, under 510(k) number K950239.

Who is the listed applicant for SENSIMATIC 500SE?

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

What is the FDA product code for SENSIMATIC 500SE?

The FDA product code for SENSIMATIC 500SE is EKZ.

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Related Devices (Code: EKZ)

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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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