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FDA 510(k)

DYNATRON II

K-Number: K880464 · 1988-03-08

ApplicantDynatronics Laser Corp.
Decision Date1988-03-08
Product CodeLBB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DYNATRON II is the device name listed in this FDA 510(k) record. The listed applicant is Dynatronics Laser Corp.. It received FDA 510(k) clearance on 1988-03-08 under 510(k) number K880464. The device is classified under product code LBB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNATRON II?

DYNATRON II is a medical device that received FDA 510(k) clearance on 1988-03-08. The listed applicant is Dynatronics Laser Corp.. The 510(k) number is K880464.

When did DYNATRON II receive FDA 510(k) clearance?

DYNATRON II received FDA 510(k) clearance on 1988-03-08, under 510(k) number K880464.

Who is the listed applicant for DYNATRON II?

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

What is the FDA product code for DYNATRON II?

The FDA product code for DYNATRON II is LBB.

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 Dynatronics Laser Corp. 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.

K920939DYNATRON 300 ULRASOUNDK900639DYNATRON 350 EMG/BIOFEEDBACK ANALYZERK900321DYNATRON 330 BODY COMPOSITION ANALYZERK864370DYNATRON 1120 EPS (ELECTRICAL POINT STIMULATOR)

Related Devices (Code: LBB)

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.

K162412Hoggan Scientific® microFET2™Hoggan Scientific, LLCK073154FACTS HAND AND PINCH GRIP COMBOGlobal Services Group, LLCK052309DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006Saehan Corp.K042889DYNAMOMETER - MODEL FCE AND MODEL MSCAmetekK012492KADANCE 2000Kada Research, Inc.K981730DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002Nk Biotechnical Corp.

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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