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)

SIGMA 7000

K-Number: K820038 · 1983-01-26

ApplicantSigma
Decision Date1983-01-26
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SIGMA 7000 is the device name listed in this FDA 510(k) record. The listed applicant is Sigma. It received FDA 510(k) clearance on 1983-01-26 under 510(k) number K820038. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGMA 7000?

SIGMA 7000 is a medical device that received FDA 510(k) clearance on 1983-01-26. The listed applicant is Sigma. The 510(k) number is K820038.

When did SIGMA 7000 receive FDA 510(k) clearance?

SIGMA 7000 received FDA 510(k) clearance on 1983-01-26, under 510(k) number K820038.

Who is the listed applicant for SIGMA 7000?

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 SIGMA 7000?

The FDA product code for SIGMA 7000 is FRN.

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.

K962239SMART ADJUSTER (SA201)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 PUMPS

Related Devices (Code: FRN)

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.

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpK252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed CorporationK243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, 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.

↑