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FDA 510(k)

NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8

K-Number: K853134 · 1985-11-06

ApplicantErika, Inc.
Decision Date1985-11-06
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8 is the device name listed in this FDA 510(k) record. The listed applicant is Erika, Inc.. It received FDA 510(k) clearance on 1985-11-06 under 510(k) number K853134. 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 NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8?

NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8 is a medical device that received FDA 510(k) clearance on 1985-11-06. The listed applicant is Erika, Inc.. The 510(k) number is K853134.

When did NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8 receive FDA 510(k) clearance?

NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8 received FDA 510(k) clearance on 1985-11-06, under 510(k) number K853134.

Who is the listed applicant for NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8?

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

What is the FDA product code for NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8?

The FDA product code for NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8 is FRN.

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Other records listing Erika, 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.

K852309ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1K852310NATURALYTE BICARBONATE CONCENTRATE-DRY PACKK850866TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1LK850865TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1-K850654TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KIDK850655TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2

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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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