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FDA 510(k)

AUTODETECT SYRINGE

K-Number: K041590 · 2004-06-23

ApplicantIndigo Orb, Inc.
Decision Date2004-06-23
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AUTODETECT SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Indigo Orb, Inc.. It received FDA 510(k) clearance on 2004-06-23 under 510(k) number K041590. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTODETECT SYRINGE?

AUTODETECT SYRINGE is a medical device that received FDA 510(k) clearance on 2004-06-23. The listed applicant is Indigo Orb, Inc.. The 510(k) number is K041590.

When did AUTODETECT SYRINGE receive FDA 510(k) clearance?

AUTODETECT SYRINGE received FDA 510(k) clearance on 2004-06-23, under 510(k) number K041590.

Who is the listed applicant for AUTODETECT SYRINGE?

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

What is the FDA product code for AUTODETECT SYRINGE?

The FDA product code for AUTODETECT SYRINGE is FMF.

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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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