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FDA 510(k)

WARP10,WARP75

K-Number: K113231 · 2012-02-27

ApplicantQuantum Devices, Inc.
Decision Date2012-02-27
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

WARP10,WARP75 is the device name listed in this FDA 510(k) record. The listed applicant is Quantum Devices, Inc.. It received FDA 510(k) clearance on 2012-02-27 under 510(k) number K113231. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WARP10,WARP75?

WARP10,WARP75 is a medical device that received FDA 510(k) clearance on 2012-02-27. The listed applicant is Quantum Devices, Inc.. The 510(k) number is K113231.

When did WARP10,WARP75 receive FDA 510(k) clearance?

WARP10,WARP75 received FDA 510(k) clearance on 2012-02-27, under 510(k) number K113231.

Who is the listed applicant for WARP10,WARP75?

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

What is the FDA product code for WARP10,WARP75?

The FDA product code for WARP10,WARP75 is ILY.

Other records listing Quantum Devices, 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.

K032229QUANTUM WARP 10 LIGHT DELIVERY SYSTEM

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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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