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FDA 510(k)

ICP MONITOR MODEL 1000

K-Number: K844566 · 1985-08-16

ApplicantAdvanced Ultrasonic Testing & Research Corp.
Decision Date1985-08-16
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ICP MONITOR MODEL 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Ultrasonic Testing & Research Corp.. It received FDA 510(k) clearance on 1985-08-16 under 510(k) number K844566. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICP MONITOR MODEL 1000?

ICP MONITOR MODEL 1000 is a medical device that received FDA 510(k) clearance on 1985-08-16. The listed applicant is Advanced Ultrasonic Testing & Research Corp.. The 510(k) number is K844566.

When did ICP MONITOR MODEL 1000 receive FDA 510(k) clearance?

ICP MONITOR MODEL 1000 received FDA 510(k) clearance on 1985-08-16, under 510(k) number K844566.

Who is the listed applicant for ICP MONITOR MODEL 1000?

The FDA 510(k) record lists Advanced Ultrasonic Testing & Research Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ICP MONITOR MODEL 1000?

The FDA product code for ICP MONITOR MODEL 1000 is GWM.

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Related Devices (Code: GWM)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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