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FDA 510(k)

NIIC MODEL: DX901 ASPIRATION SYSTEM

K-Number: K900185 · 1990-05-24

Decision Date1990-05-24
Product CodeJFL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NIIC MODEL: DX901 ASPIRATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Niic U.S.A., Inc.. It received FDA 510(k) clearance on 1990-05-24 under 510(k) number K900185. The device is classified under product code JFL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIIC MODEL: DX901 ASPIRATION SYSTEM?

NIIC MODEL: DX901 ASPIRATION SYSTEM is a medical device that received FDA 510(k) clearance on 1990-05-24. The listed applicant is Niic U.S.A., Inc.. The 510(k) number is K900185.

When did NIIC MODEL: DX901 ASPIRATION SYSTEM receive FDA 510(k) clearance?

NIIC MODEL: DX901 ASPIRATION SYSTEM received FDA 510(k) clearance on 1990-05-24, under 510(k) number K900185.

Who is the listed applicant for NIIC MODEL: DX901 ASPIRATION SYSTEM?

The FDA 510(k) record lists Niic U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NIIC MODEL: DX901 ASPIRATION SYSTEM?

The FDA product code for NIIC MODEL: DX901 ASPIRATION SYSTEM is JFL.

Related Clinical Trials

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.

Other records listing Niic U.S.A., 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.

View all 16 devices →

Related Devices (Code: JFL)

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.

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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