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FDA 510(k)

SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP

K-Number: K043204 · 2005-03-30

ApplicantSgarlato Laboratories, Inc.
Decision Date2005-03-30
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Sgarlato Laboratories, Inc.. It received FDA 510(k) clearance on 2005-03-30 under 510(k) number K043204. 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 SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP?

SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP is a medical device that received FDA 510(k) clearance on 2005-03-30. The listed applicant is Sgarlato Laboratories, Inc.. The 510(k) number is K043204.

When did SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP receive FDA 510(k) clearance?

SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP received FDA 510(k) clearance on 2005-03-30, under 510(k) number K043204.

Who is the listed applicant for SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP?

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

What is the FDA product code for SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP?

The FDA product code for SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP is FRN.

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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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