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FDA 510(k)

MICROJECT MODEL PCA-1

K-Number: K965222 · 1997-06-19

ApplicantMicroject, Inc.
Decision Date1997-06-19
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MICROJECT MODEL PCA-1 is the device name listed in this FDA 510(k) record. The listed applicant is Microject, Inc.. It received FDA 510(k) clearance on 1997-06-19 under 510(k) number K965222. The device is classified under product code MEB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROJECT MODEL PCA-1?

MICROJECT MODEL PCA-1 is a medical device that received FDA 510(k) clearance on 1997-06-19. The listed applicant is Microject, Inc.. The 510(k) number is K965222.

When did MICROJECT MODEL PCA-1 receive FDA 510(k) clearance?

MICROJECT MODEL PCA-1 received FDA 510(k) clearance on 1997-06-19, under 510(k) number K965222.

Who is the listed applicant for MICROJECT MODEL PCA-1?

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

What is the FDA product code for MICROJECT MODEL PCA-1?

The FDA product code for MICROJECT MODEL PCA-1 is MEB.

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 Microject, 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.

K941595MICROJECT MODEL 200, MODEL 30, AND MODEL TPN-5

Related Devices (Code: MEB)

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.

K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte. , Ltd.K240624InfuLifeFirst Medical Source, LLCK242152SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte. , Ltd.K181360ON-Q* Pump with BolusHalyard HealthK151650SMARTez elastomeric infusion pumpEpic Medical Pte. , Ltd.K131247MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEMMfs - Medical Flow Systems, Ltd.

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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