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FDA 510(k)

PEFECT SHOT

K-Number: K972019 · 1997-07-03

ApplicantInternational Imaging Electronics
Decision Date1997-07-03
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PEFECT SHOT is the device name listed in this FDA 510(k) record. The listed applicant is International Imaging Electronics. It received FDA 510(k) clearance on 1997-07-03 under 510(k) number K972019. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEFECT SHOT?

PEFECT SHOT is a medical device that received FDA 510(k) clearance on 1997-07-03. The listed applicant is International Imaging Electronics. The 510(k) number is K972019.

When did PEFECT SHOT receive FDA 510(k) clearance?

PEFECT SHOT received FDA 510(k) clearance on 1997-07-03, under 510(k) number K972019.

Who is the listed applicant for PEFECT SHOT?

The FDA 510(k) record lists International Imaging Electronics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PEFECT SHOT?

The FDA product code for PEFECT SHOT is EIA.

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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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