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FDA 510(k)

LADD MEDICAL S-2000

K-Number: K862012 · 1986-06-09

ApplicantLadd Research Industries, Inc.
Decision Date1986-06-09
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LADD MEDICAL S-2000 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 1986-06-09 under 510(k) number K862012. 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 LADD MEDICAL S-2000?

LADD MEDICAL S-2000 is a medical device that received FDA 510(k) clearance on 1986-06-09. The listed applicant is Ladd Research Industries, Inc.. The 510(k) number is K862012.

When did LADD MEDICAL S-2000 receive FDA 510(k) clearance?

LADD MEDICAL S-2000 received FDA 510(k) clearance on 1986-06-09, under 510(k) number K862012.

Who is the listed applicant for LADD MEDICAL S-2000?

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 LADD MEDICAL S-2000?

The FDA product code for LADD MEDICAL S-2000 is GWM.

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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.

K893395MINI-MONITOR J7000 ICPK862820LADD/STERITEK ICP MONITOR, CAT. NO. P3000

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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