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FDA 510(k)

SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP

K-Number: K941984 · 1994-07-19

ApplicantSabratek Corp.
Decision Date1994-07-19
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Sabratek Corp.. It received FDA 510(k) clearance on 1994-07-19 under 510(k) number K941984. 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 SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP?

SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1994-07-19. The listed applicant is Sabratek Corp.. The 510(k) number is K941984.

When did SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP receive FDA 510(k) clearance?

SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP received FDA 510(k) clearance on 1994-07-19, under 510(k) number K941984.

Who is the listed applicant for SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP?

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

What is the FDA product code for SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP?

The FDA product code for SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP is FRN.

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Other records listing Sabratek 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.

K983355SABRATEK APM-2000 AMBULATORY PATIENT MONTOR, TRANSCUTANEOUS TEMPERATURE MONITORK980751SABRATEK 4040 INFUSION PUMPK980619SABRATEK PATIENT HOME MANAGEMENT SYSTEMK9552583030 INFUSION PUMPK944293SABRATEK SABSIL SETSK914589SABRATEK 3030 INFUSION PUMP

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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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