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FDA 510(k)

SIGMA 7000-6000 INFUSION PUMPS

K-Number: K830038 · 1983-01-26

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

Device Summary

SIGMA 7000-6000 INFUSION PUMPS 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 K830038. 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 7000-6000 INFUSION PUMPS?

SIGMA 7000-6000 INFUSION PUMPS is a medical device that received FDA 510(k) clearance on 1983-01-26. The listed applicant is Sigma. The 510(k) number is K830038.

When did SIGMA 7000-6000 INFUSION PUMPS receive FDA 510(k) clearance?

SIGMA 7000-6000 INFUSION PUMPS received FDA 510(k) clearance on 1983-01-26, under 510(k) number K830038.

Who is the listed applicant for SIGMA 7000-6000 INFUSION PUMPS?

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 7000-6000 INFUSION PUMPS?

The FDA product code for SIGMA 7000-6000 INFUSION PUMPS 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.

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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 &K820038SIGMA 7000

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.

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