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FDA 510(k)

AMSET PLD SYSTEM

K-Number: K905014 · 1991-04-01

ApplicantAdvanced Med/Surg, Inc.
Decision Date1991-04-01
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AMSET PLD SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Med/Surg, Inc.. It received FDA 510(k) clearance on 1991-04-01 under 510(k) number K905014. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMSET PLD SYSTEM?

AMSET PLD SYSTEM is a medical device that received FDA 510(k) clearance on 1991-04-01. The listed applicant is Advanced Med/Surg, Inc.. The 510(k) number is K905014.

When did AMSET PLD SYSTEM receive FDA 510(k) clearance?

AMSET PLD SYSTEM received FDA 510(k) clearance on 1991-04-01, under 510(k) number K905014.

Who is the listed applicant for AMSET PLD SYSTEM?

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

What is the FDA product code for AMSET PLD SYSTEM?

The FDA product code for AMSET PLD SYSTEM is HRX.

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Other records listing Advanced Med/Surg, Inc. 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: HRX)

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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