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FDA 510(k)

STELLAR MODEL HS-04

K-Number: K973223 · 1998-02-18

ApplicantStellar Medical Corp.
Decision Date1998-02-18
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

STELLAR MODEL HS-04 is the device name listed in this FDA 510(k) record. The listed applicant is Stellar Medical Corp.. It received FDA 510(k) clearance on 1998-02-18 under 510(k) number K973223. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STELLAR MODEL HS-04?

STELLAR MODEL HS-04 is a medical device that received FDA 510(k) clearance on 1998-02-18. The listed applicant is Stellar Medical Corp.. The 510(k) number is K973223.

When did STELLAR MODEL HS-04 receive FDA 510(k) clearance?

STELLAR MODEL HS-04 received FDA 510(k) clearance on 1998-02-18, under 510(k) number K973223.

Who is the listed applicant for STELLAR MODEL HS-04?

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

What is the FDA product code for STELLAR MODEL HS-04?

The FDA product code for STELLAR MODEL HS-04 is IPF.

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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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