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FDA 510(k)

ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX

K-Number: K011601 · 2001-06-08

ApplicantArdo Medical AG
Decision Date2001-06-08
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX is the device name listed in this FDA 510(k) record. The listed applicant is Ardo Medical AG. It received FDA 510(k) clearance on 2001-06-08 under 510(k) number K011601. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX?

ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX is a medical device that received FDA 510(k) clearance on 2001-06-08. The listed applicant is Ardo Medical AG. The 510(k) number is K011601.

When did ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX receive FDA 510(k) clearance?

ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX received FDA 510(k) clearance on 2001-06-08, under 510(k) number K011601.

Who is the listed applicant for ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX?

The FDA 510(k) record lists Ardo Medical AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX?

The FDA product code for ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX is BTA.

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Other records listing Ardo Medical AG 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: BTA)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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