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FDA 510(k)

IMPACT, MODELS 306/307

K-Number: K820338 · 1982-03-02

ApplicantImpact Instrumentation, Inc.
Decision Date1982-03-02
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IMPACT, MODELS 306/307 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 1982-03-02 under 510(k) number K820338. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPACT, MODELS 306/307?

IMPACT, MODELS 306/307 is a medical device that received FDA 510(k) clearance on 1982-03-02. The listed applicant is Impact Instrumentation, Inc.. The 510(k) number is K820338.

When did IMPACT, MODELS 306/307 receive FDA 510(k) clearance?

IMPACT, MODELS 306/307 received FDA 510(k) clearance on 1982-03-02, under 510(k) number K820338.

Who is the listed applicant for IMPACT, MODELS 306/307?

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, MODELS 306/307?

The FDA product code for IMPACT, MODELS 306/307 is BTA.

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Related Devices (Code: BTA)

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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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