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FDA 510(k)

MEDI-DX 7000

K-Number: K964622 · 1997-12-01

ApplicantNeuro-Diagnostic Assoc.
Decision Date1997-12-01
Product CodeLLN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MEDI-DX 7000 is the device name listed in this FDA 510(k) record. The listed applicant is Neuro-Diagnostic Assoc.. It received FDA 510(k) clearance on 1997-12-01 under 510(k) number K964622. The device is classified under product code LLN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDI-DX 7000?

MEDI-DX 7000 is a medical device that received FDA 510(k) clearance on 1997-12-01. The listed applicant is Neuro-Diagnostic Assoc.. The 510(k) number is K964622.

When did MEDI-DX 7000 receive FDA 510(k) clearance?

MEDI-DX 7000 received FDA 510(k) clearance on 1997-12-01, under 510(k) number K964622.

Who is the listed applicant for MEDI-DX 7000?

The FDA 510(k) record lists Neuro-Diagnostic Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDI-DX 7000?

The FDA product code for MEDI-DX 7000 is LLN.

Other records listing Neuro-Diagnostic Assoc. 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.

K980866MEDI-DX 7000 CPT WITH AMREX ELECTRODES

Related Devices (Code: LLN)

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.

K072882PAIN VISION, MODEL PS-2100Osachi Co., Ltd.K030829VPT METERXilas Medical, Inc.K010981GSA GENITO SENSORY ANALYZERMedoc Ltd. Advanced Medical SystemsK964815AP-4000, AIR PULSE SENSORY STIMULATORPentax Precision Instrument Corp.K970180VSA 3000 VIBRATORYN SENSORY ANALYZEREare Consulting ServiceK934368NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001Nk Biotechnical Engineering Co.

Official Source

View on FDA Database →

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

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