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FDA 510(k)

ES-1000SP II SMART DOP

K-Number: K903026 · 1991-02-26

ApplicantKoven and Assoc., Inc.
Decision Date1991-02-26
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ES-1000SP II SMART DOP is the device name listed in this FDA 510(k) record. The listed applicant is Koven and Assoc., Inc.. It received FDA 510(k) clearance on 1991-02-26 under 510(k) number K903026. 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 ES-1000SP II SMART DOP?

ES-1000SP II SMART DOP is a medical device that received FDA 510(k) clearance on 1991-02-26. The listed applicant is Koven and Assoc., Inc.. The 510(k) number is K903026.

When did ES-1000SP II SMART DOP receive FDA 510(k) clearance?

ES-1000SP II SMART DOP received FDA 510(k) clearance on 1991-02-26, under 510(k) number K903026.

Who is the listed applicant for ES-1000SP II SMART DOP?

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

What is the FDA product code for ES-1000SP II SMART DOP?

The FDA product code for ES-1000SP II SMART DOP is DPW.

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Other records listing Koven and Assoc., Inc. as applicant

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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

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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