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FDA 510(k)

I.V. START KIT

K-Number: K780222 · 1978-03-28

ApplicantMarion Laboratories, Inc.
Decision Date1978-03-28
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

I.V. START KIT is the device name listed in this FDA 510(k) record. The listed applicant is Marion Laboratories, Inc.. It received FDA 510(k) clearance on 1978-03-28 under 510(k) number K780222. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. 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 1978-03-28. The listed applicant is Marion Laboratories, Inc.. The 510(k) number is K780222.

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

I.V. START KIT received FDA 510(k) clearance on 1978-03-28, under 510(k) number K780222.

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

The FDA 510(k) record lists Marion Laboratories, Inc. 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 FRO. This falls under the Anesthesiology category.

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Other records listing Marion Laboratories, Inc. as applicant

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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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