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FDA 510(k)

SMART ADJUSTER (SA201)

K-Number: K962239 · 1997-01-10

ApplicantSigma
Decision Date1997-01-10
Product CodeLXM
DecisionSubstantially Equivalent

Device Summary

SMART ADJUSTER (SA201) is the device name listed in this FDA 510(k) record. The listed applicant is Sigma. It received FDA 510(k) clearance on 1997-01-10 under 510(k) number K962239. The device is classified under product code LXM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMART ADJUSTER (SA201)?

SMART ADJUSTER (SA201) is a medical device that received FDA 510(k) clearance on 1997-01-10. The listed applicant is Sigma. The 510(k) number is K962239.

When did SMART ADJUSTER (SA201) receive FDA 510(k) clearance?

SMART ADJUSTER (SA201) received FDA 510(k) clearance on 1997-01-10, under 510(k) number K962239.

Who is the listed applicant for SMART ADJUSTER (SA201)?

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

What is the FDA product code for SMART ADJUSTER (SA201)?

The FDA product code for SMART ADJUSTER (SA201) is LXM.

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 Sigma 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.

K926191SIGMA 7000 AND SIGMA70002K851738MCDB-105 MED. M6395, W/L-GLUTAMINE, 25M M HERPES &K851737MCDB-110 MED. M6520 W/L-GLUTAMINE-25M M HERPES &K830038SIGMA 7000-6000 INFUSION PUMPSK820038SIGMA 7000

Related Devices (Code: LXM)

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.

K234036SONIK MONARK 100Neuro Spinal Innovation, Inc.K192629SpinalyticsOptima Health Solutions International Corp.K172536Atlas Percussion Adjusting InstrumentSpinalight, Inc.K160278VSTAAR AdjusteRSpinal Acoustics, LLCK112606ACTIVATOR V-EActivator Methods International, Ltd.K082218MAX ADJUSTING INSTRUMENTManna Omni International, 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.

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