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FDA 510(k)

VELCOM-100

K-Number: K863210 · 1986-11-26

ApplicantWaters Instruments, Inc.
Decision Date1986-11-26
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VELCOM-100 is the device name listed in this FDA 510(k) record. The listed applicant is Waters Instruments, Inc.. It received FDA 510(k) clearance on 1986-11-26 under 510(k) number K863210. 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 VELCOM-100?

VELCOM-100 is a medical device that received FDA 510(k) clearance on 1986-11-26. The listed applicant is Waters Instruments, Inc.. The 510(k) number is K863210.

When did VELCOM-100 receive FDA 510(k) clearance?

VELCOM-100 received FDA 510(k) clearance on 1986-11-26, under 510(k) number K863210.

Who is the listed applicant for VELCOM-100?

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

What is the FDA product code for VELCOM-100?

The FDA product code for VELCOM-100 is DPW.

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Other records listing Waters Instruments, Inc. as applicant

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K053169RM3 RENAL PRESERVATION SYSTEMK042224RM3 RENAL PRESERVATION SYSTEMK971571RM3 RENAL PRESERVATION SYSTEM--CONTROL UNITK921519OXICOM-2100K911207OXICOMPLUSK862161OSC-80 OXIMETER

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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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