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FDA 510(k)

Dual Pump Pack

K-Number: K160236 · 2016-04-27

ApplicantAbbott Medical Optics, Inc.
Decision Date2016-04-27
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Dual Pump Pack is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Medical Optics, Inc.. It received FDA 510(k) clearance on 2016-04-27 under 510(k) number K160236. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dual Pump Pack?

Dual Pump Pack is a medical device that received FDA 510(k) clearance on 2016-04-27. The listed applicant is Abbott Medical Optics, Inc.. The 510(k) number is K160236.

When did Dual Pump Pack receive FDA 510(k) clearance?

Dual Pump Pack received FDA 510(k) clearance on 2016-04-27, under 510(k) number K160236.

Who is the listed applicant for Dual Pump Pack?

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

What is the FDA product code for Dual Pump Pack?

The FDA product code for Dual Pump Pack is HQC.

Other records listing Abbott Medical Optics, 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.

K170322Catalys Precision Laser System

Related Devices (Code: HQC)

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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