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FDA 510(k)

MODEL FT-100 INTRACRANIAL PRESSURE MONITOR

K-Number: K890468 · 1989-04-26

ApplicantPearl Instruments Corp.
Decision Date1989-04-26
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODEL FT-100 INTRACRANIAL PRESSURE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Pearl Instruments Corp.. It received FDA 510(k) clearance on 1989-04-26 under 510(k) number K890468. 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 MODEL FT-100 INTRACRANIAL PRESSURE MONITOR?

MODEL FT-100 INTRACRANIAL PRESSURE MONITOR is a medical device that received FDA 510(k) clearance on 1989-04-26. The listed applicant is Pearl Instruments Corp.. The 510(k) number is K890468.

When did MODEL FT-100 INTRACRANIAL PRESSURE MONITOR receive FDA 510(k) clearance?

MODEL FT-100 INTRACRANIAL PRESSURE MONITOR received FDA 510(k) clearance on 1989-04-26, under 510(k) number K890468.

Who is the listed applicant for MODEL FT-100 INTRACRANIAL PRESSURE MONITOR?

The FDA 510(k) record lists Pearl Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL FT-100 INTRACRANIAL PRESSURE MONITOR?

The FDA product code for MODEL FT-100 INTRACRANIAL PRESSURE MONITOR is GWM.

Related Clinical Trials

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Other records listing Pearl Instruments Corp. as applicant

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.

K896834MODEL BT-1 FOT BOLT INSTALLATION KIT

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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