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FDA 510(k)

PROVIDER ONE INFUSION SYSTEM

K-Number: K882102 · 1988-08-12

ApplicantPancretec, Inc.
Decision Date1988-08-12
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROVIDER ONE INFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pancretec, Inc.. It received FDA 510(k) clearance on 1988-08-12 under 510(k) number K882102. 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 PROVIDER ONE INFUSION SYSTEM?

PROVIDER ONE INFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 1988-08-12. The listed applicant is Pancretec, Inc.. The 510(k) number is K882102.

When did PROVIDER ONE INFUSION SYSTEM receive FDA 510(k) clearance?

PROVIDER ONE INFUSION SYSTEM received FDA 510(k) clearance on 1988-08-12, under 510(k) number K882102.

Who is the listed applicant for PROVIDER ONE INFUSION SYSTEM?

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

What is the FDA product code for PROVIDER ONE INFUSION SYSTEM?

The FDA product code for PROVIDER ONE INFUSION SYSTEM is FRN.

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Other records listing Pancretec, 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.

K871806PROVIDER IV. MODEL 5000 INFUSION DEVICEK844078PROVIDER PA 3000 INFUSION SYSTEMK843463PROVIDER BAG SPIKE W/12 MICROBORE EXTENK841373PROVIDER IV MODEL 2000 INFUSIN SYSK841017PROVIDER INFUSION SETK841027PROVIDER SITE PREP & CHECK STRIP KIT

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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.

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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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