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FDA 510(k)

SHEAR FORCE GAUGE

K-Number: K864330 · 1987-01-06

ApplicantAmerican Edwards Laboratories
Decision Date1987-01-06
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SHEAR FORCE GAUGE is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1987-01-06 under 510(k) number K864330. The device is classified under product code DXE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHEAR FORCE GAUGE?

SHEAR FORCE GAUGE is a medical device that received FDA 510(k) clearance on 1987-01-06. The listed applicant is American Edwards Laboratories. The 510(k) number is K864330.

When did SHEAR FORCE GAUGE receive FDA 510(k) clearance?

SHEAR FORCE GAUGE received FDA 510(k) clearance on 1987-01-06, under 510(k) number K864330.

Who is the listed applicant for SHEAR FORCE GAUGE?

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

What is the FDA product code for SHEAR FORCE GAUGE?

The FDA product code for SHEAR FORCE GAUGE is DXE.

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Other records listing American Edwards Laboratories as applicant

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Related Devices (Code: DXE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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