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FDA 510(k)

I.V. START KIT

K-Number: K950686 · 1996-10-24

ApplicantJames J. Schramm
Decision Date1996-10-24
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

I.V. START KIT is the device name listed in this FDA 510(k) record. The listed applicant is James J. Schramm. It received FDA 510(k) clearance on 1996-10-24 under 510(k) number K950686. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I.V. START KIT?

I.V. START KIT is a medical device that received FDA 510(k) clearance on 1996-10-24. The listed applicant is James J. Schramm. The 510(k) number is K950686.

When did I.V. START KIT receive FDA 510(k) clearance?

I.V. START KIT received FDA 510(k) clearance on 1996-10-24, under 510(k) number K950686.

Who is the listed applicant for I.V. START KIT?

The FDA 510(k) record lists James J. Schramm as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I.V. START KIT?

The FDA product code for I.V. START KIT is FMI.

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Related Devices (Code: FMI)

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

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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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