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FDA 510(k)

MINI-MONITOR J7000 ICP

K-Number: K893395 · 1989-11-22

ApplicantLadd Research Industries, Inc.
Decision Date1989-11-22
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MINI-MONITOR J7000 ICP is the device name listed in this FDA 510(k) record. The listed applicant is Ladd Research Industries, Inc.. It received FDA 510(k) clearance on 1989-11-22 under 510(k) number K893395. 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 MINI-MONITOR J7000 ICP?

MINI-MONITOR J7000 ICP is a medical device that received FDA 510(k) clearance on 1989-11-22. The listed applicant is Ladd Research Industries, Inc.. The 510(k) number is K893395.

When did MINI-MONITOR J7000 ICP receive FDA 510(k) clearance?

MINI-MONITOR J7000 ICP received FDA 510(k) clearance on 1989-11-22, under 510(k) number K893395.

Who is the listed applicant for MINI-MONITOR J7000 ICP?

The FDA 510(k) record lists Ladd Research Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MINI-MONITOR J7000 ICP?

The FDA product code for MINI-MONITOR J7000 ICP 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 Ladd Research Industries, Inc. 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.

K862820LADD/STERITEK ICP MONITOR, CAT. NO. P3000K862012LADD MEDICAL S-2000

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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