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FDA 510(k)

CRITIVIEW, MODEL CRV3

K-Number: K062977 · 2007-02-28

ApplicantCritisense , Ltd.
Decision Date2007-02-28
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CRITIVIEW, MODEL CRV3 is the device name listed in this FDA 510(k) record. The listed applicant is Critisense , Ltd.. It received FDA 510(k) clearance on 2007-02-28 under 510(k) number K062977. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRITIVIEW, MODEL CRV3?

CRITIVIEW, MODEL CRV3 is a medical device that received FDA 510(k) clearance on 2007-02-28. The listed applicant is Critisense , Ltd.. The 510(k) number is K062977.

When did CRITIVIEW, MODEL CRV3 receive FDA 510(k) clearance?

CRITIVIEW, MODEL CRV3 received FDA 510(k) clearance on 2007-02-28, under 510(k) number K062977.

Who is the listed applicant for CRITIVIEW, MODEL CRV3?

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

What is the FDA product code for CRITIVIEW, MODEL CRV3?

The FDA product code for CRITIVIEW, MODEL CRV3 is DPW.

Related Clinical Trials

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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Other records listing Critisense , 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.

K051145CRITIVIEW

Related Devices (Code: DPW)

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.

K260700BlueDop Vascular ExpertBlueDop Medical, Ltd.K252810FloPatch FP120Flosonics MedicalK251904VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)Remington Medical, Inc.K251114FloPatch FP120Flosonics MedicalK243852Elfor-LElfi-Tech , Ltd.K241583VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)Remington Medical, Inc.

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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