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FDA 510(k)

NAMIC ARIA(TM) INFLATION DEVICE

K-Number: K940542 · 1994-04-18

ApplicantAmerican Medical Systems, Inc.
Decision Date1994-04-18
Product CodeEZN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NAMIC ARIA(TM) INFLATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Systems, Inc.. It received FDA 510(k) clearance on 1994-04-18 under 510(k) number K940542. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAMIC ARIA(TM) INFLATION DEVICE?

NAMIC ARIA(TM) INFLATION DEVICE is a medical device that received FDA 510(k) clearance on 1994-04-18. The listed applicant is American Medical Systems, Inc.. The 510(k) number is K940542.

When did NAMIC ARIA(TM) INFLATION DEVICE receive FDA 510(k) clearance?

NAMIC ARIA(TM) INFLATION DEVICE received FDA 510(k) clearance on 1994-04-18, under 510(k) number K940542.

Who is the listed applicant for NAMIC ARIA(TM) INFLATION DEVICE?

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

What is the FDA product code for NAMIC ARIA(TM) INFLATION DEVICE?

The FDA product code for NAMIC ARIA(TM) INFLATION DEVICE is EZN.

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Other records listing American Medical Systems, Inc. as applicant

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Related Devices (Code: EZN)

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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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