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FDA 510(k)

SHARPS CONTAINER MODEL# SC001

K-Number: K963830 · 1997-02-10

ApplicantImage Medical, Inc.
Decision Date1997-02-10
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SHARPS CONTAINER MODEL# SC001 is the device name listed in this FDA 510(k) record. The listed applicant is Image Medical, Inc.. It received FDA 510(k) clearance on 1997-02-10 under 510(k) number K963830. 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 SHARPS CONTAINER MODEL# SC001?

SHARPS CONTAINER MODEL# SC001 is a medical device that received FDA 510(k) clearance on 1997-02-10. The listed applicant is Image Medical, Inc.. The 510(k) number is K963830.

When did SHARPS CONTAINER MODEL# SC001 receive FDA 510(k) clearance?

SHARPS CONTAINER MODEL# SC001 received FDA 510(k) clearance on 1997-02-10, under 510(k) number K963830.

Who is the listed applicant for SHARPS CONTAINER MODEL# SC001?

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

What is the FDA product code for SHARPS CONTAINER MODEL# SC001?

The FDA product code for SHARPS CONTAINER MODEL# SC001 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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