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FDA 510(k)

IMPACT MODEL 316

K-Number: K842050 · 1984-08-03

ApplicantImpact Instrumentation, Inc.
Decision Date1984-08-03
Product CodeJCX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IMPACT MODEL 316 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 1984-08-03 under 510(k) number K842050. 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 316?

IMPACT MODEL 316 is a medical device that received FDA 510(k) clearance on 1984-08-03. The listed applicant is Impact Instrumentation, Inc.. The 510(k) number is K842050.

When did IMPACT MODEL 316 receive FDA 510(k) clearance?

IMPACT MODEL 316 received FDA 510(k) clearance on 1984-08-03, under 510(k) number K842050.

Who is the listed applicant for IMPACT MODEL 316?

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 316?

The FDA product code for IMPACT MODEL 316 is JCX.

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Other records listing Impact Instrumentation, Inc. as applicant

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Related Devices (Code: JCX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250964Protable Phlegm Suction Unit (JMA D01)Jiangsu Jumao X-Care Medical Equipment Co., Ltd.K243638MV Flow Aspiration Pump (MVFLOWPMP01)MicroventionK251111CaryExcitus ASK243418Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate TubingMicro Therapeutics, Inc. d/b/a ev3 NeurovascularK233428Easycess Aspiration PumpGuangzhou Easycess Medical Co.,LtdK222552120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)Stryker Instruments

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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