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FDA 510(k)

IMPEDANCE PHLEBOGRAPH/PHOTOPLETHYSMOGRAPH-DVT-2000

K-Number: K911194 · 1991-09-30

ApplicantRjl Systems, Inc.
Decision Date1991-09-30
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IMPEDANCE PHLEBOGRAPH/PHOTOPLETHYSMOGRAPH-DVT-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Rjl Systems, Inc.. It received FDA 510(k) clearance on 1991-09-30 under 510(k) number K911194. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPEDANCE PHLEBOGRAPH/PHOTOPLETHYSMOGRAPH-DVT-2000?

IMPEDANCE PHLEBOGRAPH/PHOTOPLETHYSMOGRAPH-DVT-2000 is a medical device that received FDA 510(k) clearance on 1991-09-30. The listed applicant is Rjl Systems, Inc.. The 510(k) number is K911194.

When did IMPEDANCE PHLEBOGRAPH/PHOTOPLETHYSMOGRAPH-DVT-2000 receive FDA 510(k) clearance?

IMPEDANCE PHLEBOGRAPH/PHOTOPLETHYSMOGRAPH-DVT-2000 received FDA 510(k) clearance on 1991-09-30, under 510(k) number K911194.

Who is the listed applicant for IMPEDANCE PHLEBOGRAPH/PHOTOPLETHYSMOGRAPH-DVT-2000?

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

What is the FDA product code for IMPEDANCE PHLEBOGRAPH/PHOTOPLETHYSMOGRAPH-DVT-2000?

The FDA product code for IMPEDANCE PHLEBOGRAPH/PHOTOPLETHYSMOGRAPH-DVT-2000 is DSB.

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.

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Other records listing Rjl 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.

K070999BC (BODY COMPOSITION SOFTWARE)K862383MODIFIED MODEL BIA-103 BODY COMPOSITION ANALYZERK830292BIOELECTRICAL IMPEDANCE ANALYZER #101

Related Devices (Code: DSB)

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.

K260224MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)ImpediMed LimitedK250634BCM2-Body Composition MonitorFresenius Medical Care Renal Therapies Group, LLCK243727Re:BalansMode Sensors ASK250922Edema Guard Monitor (EGM) CardioSet-001Cardioset Medical , Ltd.K232089SOZO ProImpediMed LimitedK223217Zynex Monitoring System, Model CM-1600Zynex Medical, Inc.

Official Source

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