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FDA 510(k)

VRLXP, MODEL XP

K-Number: K091732 · 2010-03-04

ApplicantDeep Breeze , Ltd.
Decision Date2010-03-04
Product CodeOCR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VRLXP, MODEL XP is the device name listed in this FDA 510(k) record. The listed applicant is Deep Breeze , Ltd.. It received FDA 510(k) clearance on 2010-03-04 under 510(k) number K091732. The device is classified under product code OCR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VRLXP, MODEL XP?

VRLXP, MODEL XP is a medical device that received FDA 510(k) clearance on 2010-03-04. The listed applicant is Deep Breeze , Ltd.. The 510(k) number is K091732.

When did VRLXP, MODEL XP receive FDA 510(k) clearance?

VRLXP, MODEL XP received FDA 510(k) clearance on 2010-03-04, under 510(k) number K091732.

Who is the listed applicant for VRLXP, MODEL XP?

The FDA 510(k) record lists Deep Breeze , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VRLXP, MODEL XP?

The FDA product code for VRLXP, MODEL XP is OCR.

Related Clinical Trials

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Other records listing Deep Breeze , Ltd. 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.

K073582VRIICU SYSTEMK061495VR LUNG ELECTROSONOGRAPH

Related Devices (Code: OCR)

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.

K073582VRIICU SYSTEMDeep Breeze , Ltd.K061495VR LUNG ELECTROSONOGRAPHDeep Breeze , Ltd.

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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