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FDA 510(k)

VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX

K-Number: K011702 · 2001-12-21

ApplicantVertis Neuroscience, Inc.
Decision Date2001-12-21
Product CodeNHI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX is the device name listed in this FDA 510(k) record. The listed applicant is Vertis Neuroscience, Inc.. It received FDA 510(k) clearance on 2001-12-21 under 510(k) number K011702. The device is classified under product code NHI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX?

VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX is a medical device that received FDA 510(k) clearance on 2001-12-21. The listed applicant is Vertis Neuroscience, Inc.. The 510(k) number is K011702.

When did VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX receive FDA 510(k) clearance?

VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX received FDA 510(k) clearance on 2001-12-21, under 510(k) number K011702.

Who is the listed applicant for VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX?

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

What is the FDA product code for VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX?

The FDA product code for VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX is NHI.

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Other records listing Vertis Neuroscience, 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.

K022241VERTIS PNT CONTROL UNIT, MODEL CU 100; VERTIS PNT SAFEGUIDE-CERVICAL, MODEL SG 102-XXX

Related Devices (Code: NHI)

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.

K223306SPRINT Peripheral Nerve Stimulation (PNS) SystemSpr Therapeutics, Inc.K221425Primary ReliefDyansys, Inc.K220397ANSiStim-PPDyansys, Inc.K213188Primary ReliefDyansys, Inc.K212859First ReliefDyansys, Inc.K211801SPRINT PNS SystemSpr Therapeutics, Inc.

Official Source

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

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