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FDA 510(k)

IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER

K-Number: K882138 · 1988-11-07

ApplicantImex Medical Systems, Inc.
Decision Date1988-11-07
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Imex Medical Systems, Inc.. It received FDA 510(k) clearance on 1988-11-07 under 510(k) number K882138. 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 IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER?

IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER is a medical device that received FDA 510(k) clearance on 1988-11-07. The listed applicant is Imex Medical Systems, Inc.. The 510(k) number is K882138.

When did IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER receive FDA 510(k) clearance?

IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER received FDA 510(k) clearance on 1988-11-07, under 510(k) number K882138.

Who is the listed applicant for IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER?

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

What is the FDA product code for IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER?

The FDA product code for IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER is DPW.

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Other records listing Imex Medical Systems, Inc. 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.

K973556IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000K973562IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9100K973336IMEX STETHODOPK970156IMEX FUTURALDOP PROK942243IMEX 8000 PERSONAL CASCULAR LABK944196IMWXDOP IR

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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

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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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