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FDA 510(k)

CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS

K-Number: K011487 · 2001-11-21

ApplicantSomanetics Corp.
Decision Date2001-11-21
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS is the device name listed in this FDA 510(k) record. The listed applicant is Somanetics Corp.. It received FDA 510(k) clearance on 2001-11-21 under 510(k) number K011487. The device is classified under product code DXZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS?

CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS is a medical device that received FDA 510(k) clearance on 2001-11-21. The listed applicant is Somanetics Corp.. The 510(k) number is K011487.

When did CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS receive FDA 510(k) clearance?

CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS received FDA 510(k) clearance on 2001-11-21, under 510(k) number K011487.

Who is the listed applicant for CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS?

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

What is the FDA product code for CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS?

The FDA product code for CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS is DXZ.

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Related Devices (Code: DXZ)

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

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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