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FDA 510(k)

SWIVEL ELBOW

K-Number: K000215 · 2000-05-26

ApplicantEngineered Medical Systems
Decision Date2000-05-26
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SWIVEL ELBOW is the device name listed in this FDA 510(k) record. The listed applicant is Engineered Medical Systems. It received FDA 510(k) clearance on 2000-05-26 under 510(k) number K000215. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SWIVEL ELBOW?

SWIVEL ELBOW is a medical device that received FDA 510(k) clearance on 2000-05-26. The listed applicant is Engineered Medical Systems. The 510(k) number is K000215.

When did SWIVEL ELBOW receive FDA 510(k) clearance?

SWIVEL ELBOW received FDA 510(k) clearance on 2000-05-26, under 510(k) number K000215.

Who is the listed applicant for SWIVEL ELBOW?

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

What is the FDA product code for SWIVEL ELBOW?

The FDA product code for SWIVEL ELBOW is BZD.

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Other records listing Engineered Medical Systems as applicant

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Related Devices (Code: BZD)

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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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