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FDA 510(k)

IMPACT, MODEL E-12

K-Number: K820330 · 1982-02-23

ApplicantImpact Instrumentation, Inc.
Decision Date1982-02-23
Product CodeJCX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IMPACT, MODEL E-12 is the device name listed in this FDA 510(k) record. The listed applicant is Impact Instrumentation, Inc.. It received FDA 510(k) clearance on 1982-02-23 under 510(k) number K820330. The device is classified under product code JCX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPACT, MODEL E-12?

IMPACT, MODEL E-12 is a medical device that received FDA 510(k) clearance on 1982-02-23. The listed applicant is Impact Instrumentation, Inc.. The 510(k) number is K820330.

When did IMPACT, MODEL E-12 receive FDA 510(k) clearance?

IMPACT, MODEL E-12 received FDA 510(k) clearance on 1982-02-23, under 510(k) number K820330.

Who is the listed applicant for IMPACT, MODEL E-12?

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

What is the FDA product code for IMPACT, MODEL E-12?

The FDA product code for IMPACT, MODEL E-12 is JCX.

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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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