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FDA 510(k)

PERFUSOR M SYRINGE PUMP

K-Number: K882106 · 1988-08-11

ApplicantBurron Medical, Inc.
Decision Date1988-08-11
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PERFUSOR M SYRINGE PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Burron Medical, Inc.. It received FDA 510(k) clearance on 1988-08-11 under 510(k) number K882106. 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 PERFUSOR M SYRINGE PUMP?

PERFUSOR M SYRINGE PUMP is a medical device that received FDA 510(k) clearance on 1988-08-11. The listed applicant is Burron Medical, Inc.. The 510(k) number is K882106.

When did PERFUSOR M SYRINGE PUMP receive FDA 510(k) clearance?

PERFUSOR M SYRINGE PUMP received FDA 510(k) clearance on 1988-08-11, under 510(k) number K882106.

Who is the listed applicant for PERFUSOR M SYRINGE PUMP?

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

What is the FDA product code for PERFUSOR M SYRINGE PUMP?

The FDA product code for PERFUSOR M SYRINGE PUMP is FRN.

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Other records listing Burron Medical, Inc. 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.

K902401CELSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEMK896422BURRON AMBULATORY DRUG DELIVERY SYSTEMK884235COMBITRANS DISPOSABLE PRESSURE TRANSDUCER KITK895191ANTI-THROMBOGENIC COATING FOR CATHETERSK895192SPINOCAN(R) CONTINUOUS SPINAL TRAYK884183BURRON TEFLON-COATED GUIDEWIRE

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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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