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FDA 510(k)

EXTERNAL VENTRICULAR DRAINAGE SYS.

K-Number: K820247 · 1982-02-18

ApplicantAmerican Heyer Schulte
Decision Date1982-02-18
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EXTERNAL VENTRICULAR DRAINAGE SYS. is the device name listed in this FDA 510(k) record. The listed applicant is American Heyer Schulte. It received FDA 510(k) clearance on 1982-02-18 under 510(k) number K820247. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTERNAL VENTRICULAR DRAINAGE SYS.?

EXTERNAL VENTRICULAR DRAINAGE SYS. is a medical device that received FDA 510(k) clearance on 1982-02-18. The listed applicant is American Heyer Schulte. The 510(k) number is K820247.

When did EXTERNAL VENTRICULAR DRAINAGE SYS. receive FDA 510(k) clearance?

EXTERNAL VENTRICULAR DRAINAGE SYS. received FDA 510(k) clearance on 1982-02-18, under 510(k) number K820247.

Who is the listed applicant for EXTERNAL VENTRICULAR DRAINAGE SYS.?

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

What is the FDA product code for EXTERNAL VENTRICULAR DRAINAGE SYS.?

The FDA product code for EXTERNAL VENTRICULAR DRAINAGE SYS. is JXG.

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Other records listing American Heyer Schulte as applicant

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Related Devices (Code: JXG)

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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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