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FDA 510(k)

ACCUPUMP 901 (MODEL NUMBERS 50 & 100)

K-Number: K953382 · 1995-10-17

ApplicantPharmaceutical Infusion Technologies, Inc.
Decision Date1995-10-17
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

ACCUPUMP 901 (MODEL NUMBERS 50 & 100) is the device name listed in this FDA 510(k) record. The listed applicant is Pharmaceutical Infusion Technologies, Inc.. It received FDA 510(k) clearance on 1995-10-17 under 510(k) number K953382. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the ACCUPUMP 901 (MODEL NUMBERS 50 & 100)?

ACCUPUMP 901 (MODEL NUMBERS 50 & 100) is a medical device that received FDA 510(k) clearance on 1995-10-17. The listed applicant is Pharmaceutical Infusion Technologies, Inc.. The 510(k) number is K953382.

When did ACCUPUMP 901 (MODEL NUMBERS 50 & 100) receive FDA 510(k) clearance?

ACCUPUMP 901 (MODEL NUMBERS 50 & 100) received FDA 510(k) clearance on 1995-10-17, under 510(k) number K953382.

Who is the listed applicant for ACCUPUMP 901 (MODEL NUMBERS 50 & 100)?

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

What is the FDA product code for ACCUPUMP 901 (MODEL NUMBERS 50 & 100)?

The FDA product code for ACCUPUMP 901 (MODEL NUMBERS 50 & 100) is FRN.

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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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