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FDA 510(k)

INFUSION PUMP-MODEL 2616

K-Number: K780705 · 1978-05-19

ApplicantHarvard Apparatus, Inc.
Decision Date1978-05-19
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFUSION PUMP-MODEL 2616 is the device name listed in this FDA 510(k) record. The listed applicant is Harvard Apparatus, Inc.. It received FDA 510(k) clearance on 1978-05-19 under 510(k) number K780705. 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 INFUSION PUMP-MODEL 2616?

INFUSION PUMP-MODEL 2616 is a medical device that received FDA 510(k) clearance on 1978-05-19. The listed applicant is Harvard Apparatus, Inc.. The 510(k) number is K780705.

When did INFUSION PUMP-MODEL 2616 receive FDA 510(k) clearance?

INFUSION PUMP-MODEL 2616 received FDA 510(k) clearance on 1978-05-19, under 510(k) number K780705.

Who is the listed applicant for INFUSION PUMP-MODEL 2616?

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

What is the FDA product code for INFUSION PUMP-MODEL 2616?

The FDA product code for INFUSION PUMP-MODEL 2616 is FRN.

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Other records listing Harvard Apparatus, 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.

K970678THE HARVARD LIBRARYK952794HARVARD 2 SYRINGE PUMPK903614HARVARD/LTE LABORATORY STEAM STERILIZER AUTOCLAVEK903613HARVARD/LTE BENCHTOP STEAM STERILIZER (AUTOCLAVE)K813644MODEL 2650 HIGH CAPACITY DUAL SYRINGEK801904SYRINGE INFUSION PUMP #2716

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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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