Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PF 5050 PRESSURE UNIT, MODEL PF 5050

K-Number: K011899 · 2001-11-06

ApplicantPerimed AB
Decision Date2001-11-06
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PF 5050 PRESSURE UNIT, MODEL PF 5050 is the device name listed in this FDA 510(k) record. The listed applicant is Perimed AB. It received FDA 510(k) clearance on 2001-11-06 under 510(k) number K011899. 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 PF 5050 PRESSURE UNIT, MODEL PF 5050?

PF 5050 PRESSURE UNIT, MODEL PF 5050 is a medical device that received FDA 510(k) clearance on 2001-11-06. The listed applicant is Perimed AB. The 510(k) number is K011899.

When did PF 5050 PRESSURE UNIT, MODEL PF 5050 receive FDA 510(k) clearance?

PF 5050 PRESSURE UNIT, MODEL PF 5050 received FDA 510(k) clearance on 2001-11-06, under 510(k) number K011899.

Who is the listed applicant for PF 5050 PRESSURE UNIT, MODEL PF 5050?

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

What is the FDA product code for PF 5050 PRESSURE UNIT, MODEL PF 5050?

The FDA product code for PF 5050 PRESSURE UNIT, MODEL PF 5050 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 Perimed AB 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.

K152930PeriFlux6000K131253PERIFLUX 6000K120884PERICAM PSI

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.

↑