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FDA 510(k)

MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2

K-Number: K912446 · 1991-12-12

ApplicantVasamedics, LLC
Decision Date1991-12-12
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2 is the device name listed in this FDA 510(k) record. The listed applicant is Vasamedics, LLC. It received FDA 510(k) clearance on 1991-12-12 under 510(k) number K912446. 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 MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2?

MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2 is a medical device that received FDA 510(k) clearance on 1991-12-12. The listed applicant is Vasamedics, LLC. The 510(k) number is K912446.

When did MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2 receive FDA 510(k) clearance?

MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2 received FDA 510(k) clearance on 1991-12-12, under 510(k) number K912446.

Who is the listed applicant for MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2?

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

What is the FDA product code for MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2?

The FDA product code for MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Vasamedics, LLC 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.

K962700VENTRICULAR CATHETER BLOOD FLOW MONITORING PROBE KIT AND VENTRAFLO BLOOD FLOW MONITORING PROBE KITK961368TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KITK951832LASERFLO BLOOD PERFUSION SINGLE USE PROBES MODELS SUP-440, SUPR-434 SUP-433K951486MODEL PV2000 VASCULAR MICROLABORATORYK911763LASERFLO(R) BLOOD PERFUSION MONITOR (MODEL BPM2)

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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