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FDA 510(k)

PERSONAL INFUSION PUMP

K-Number: K864276 · 1987-03-17

ApplicantBionica, Inc.
Decision Date1987-03-17
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PERSONAL INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Bionica, Inc.. It received FDA 510(k) clearance on 1987-03-17 under 510(k) number K864276. 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 PERSONAL INFUSION PUMP?

PERSONAL INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1987-03-17. The listed applicant is Bionica, Inc.. The 510(k) number is K864276.

When did PERSONAL INFUSION PUMP receive FDA 510(k) clearance?

PERSONAL INFUSION PUMP received FDA 510(k) clearance on 1987-03-17, under 510(k) number K864276.

Who is the listed applicant for PERSONAL INFUSION PUMP?

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

What is the FDA product code for PERSONAL INFUSION PUMP?

The FDA product code for PERSONAL INFUSION PUMP 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 Bionica, 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.

K895426AMBULATORY INFUSION PUMPK875316BIONICA MDS 110 PCA

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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