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FDA 510(k)

EDSLAB PRESSURE GAUGE

K-Number: K832323 · 1983-08-11

ApplicantAmerican Edwards Laboratories
Decision Date1983-08-11
Product CodeMAV
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EDSLAB PRESSURE 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 1983-08-11 under 510(k) number K832323. The device is classified under product code MAV. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDSLAB PRESSURE GAUGE?

EDSLAB PRESSURE GAUGE is a medical device that received FDA 510(k) clearance on 1983-08-11. The listed applicant is American Edwards Laboratories. The 510(k) number is K832323.

When did EDSLAB PRESSURE GAUGE receive FDA 510(k) clearance?

EDSLAB PRESSURE GAUGE received FDA 510(k) clearance on 1983-08-11, under 510(k) number K832323.

Who is the listed applicant for EDSLAB PRESSURE 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 EDSLAB PRESSURE GAUGE?

The FDA product code for EDSLAB PRESSURE GAUGE is MAV.

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Other records listing American Edwards Laboratories as applicant

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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Related Devices (Code: MAV)

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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