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FDA 510(k)

MODEL BT-1 FOT BOLT INSTALLATION KIT

K-Number: K896834 · 1990-02-23

ApplicantPearl Instruments Corp.
Decision Date1990-02-23
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODEL BT-1 FOT BOLT INSTALLATION KIT 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 1990-02-23 under 510(k) number K896834. 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 BT-1 FOT BOLT INSTALLATION KIT?

MODEL BT-1 FOT BOLT INSTALLATION KIT is a medical device that received FDA 510(k) clearance on 1990-02-23. The listed applicant is Pearl Instruments Corp.. The 510(k) number is K896834.

When did MODEL BT-1 FOT BOLT INSTALLATION KIT receive FDA 510(k) clearance?

MODEL BT-1 FOT BOLT INSTALLATION KIT received FDA 510(k) clearance on 1990-02-23, under 510(k) number K896834.

Who is the listed applicant for MODEL BT-1 FOT BOLT INSTALLATION KIT?

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 BT-1 FOT BOLT INSTALLATION KIT?

The FDA product code for MODEL BT-1 FOT BOLT INSTALLATION KIT is GWM.

Related Clinical Trials

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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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.

K890468MODEL FT-100 INTRACRANIAL PRESSURE MONITOR

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.

K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysaK250285NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOLRaumedic AGK240821B4C System - Addition of new sensor model (BcSs-PICNIW-2000)Braincare Desenvolvimento E Inovação Tecnológica S.A.K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)Integra Lifesciences Production CorporationK201989B4C SystemBraincare Desenvolvimento E Inovacao Tecnologica S.A.K210993CereLink ICP MonitorIntegra Lifesciences Production Corporation

Official Source

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