FDA 510(k)

F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM

K-Number: K970380 · 1997-04-25

Decision Date1997-04-25

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pyng Medical Corp.. It received FDA 510(k) clearance on 1997-04-25 under 510(k) number K970380. 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 F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM?

F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 1997-04-25. The listed applicant is Pyng Medical Corp.. The 510(k) number is K970380.

When did F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM receive FDA 510(k) clearance?

F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM received FDA 510(k) clearance on 1997-04-25, under 510(k) number K970380.

Who is the listed applicant for F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM?

The FDA 510(k) record lists Pyng Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM?

The FDA product code for F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM is FMI.

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Other records listing Pyng Medical Corp. as applicant

K130487FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE K100124FASTX STERNAL INTRAOSSEOUS DEVICE K080865FAST1 INTRAOSSEOUS INFUSION SYSTEM K072487FAST1 INTRAOSSEOUS INFUSION SYSTEM

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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.