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FDA 510(k)

KING OF HEARTS SCEPTER

K-Number: K923221 · 1993-03-08

ApplicantInstromedix, Inc.
Decision Date1993-03-08
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KING OF HEARTS SCEPTER is the device name listed in this FDA 510(k) record. The listed applicant is Instromedix, Inc.. It received FDA 510(k) clearance on 1993-03-08 under 510(k) number K923221. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KING OF HEARTS SCEPTER?

KING OF HEARTS SCEPTER is a medical device that received FDA 510(k) clearance on 1993-03-08. The listed applicant is Instromedix, Inc.. The 510(k) number is K923221.

When did KING OF HEARTS SCEPTER receive FDA 510(k) clearance?

KING OF HEARTS SCEPTER received FDA 510(k) clearance on 1993-03-08, under 510(k) number K923221.

Who is the listed applicant for KING OF HEARTS SCEPTER?

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

What is the FDA product code for KING OF HEARTS SCEPTER?

The FDA product code for KING OF HEARTS SCEPTER is DPS.

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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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