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FDA 510(k)

ROUND WINDOW E-CATH

K-Number: K973740 · 1998-03-23

ApplicantNeuro-Biometrix, Inc.
Decision Date1998-03-23
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ROUND WINDOW E-CATH is the device name listed in this FDA 510(k) record. The listed applicant is Neuro-Biometrix, Inc.. It received FDA 510(k) clearance on 1998-03-23 under 510(k) number K973740. The device is classified under product code ETD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROUND WINDOW E-CATH?

ROUND WINDOW E-CATH is a medical device that received FDA 510(k) clearance on 1998-03-23. The listed applicant is Neuro-Biometrix, Inc.. The 510(k) number is K973740.

When did ROUND WINDOW E-CATH receive FDA 510(k) clearance?

ROUND WINDOW E-CATH received FDA 510(k) clearance on 1998-03-23, under 510(k) number K973740.

Who is the listed applicant for ROUND WINDOW E-CATH?

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

What is the FDA product code for ROUND WINDOW E-CATH?

The FDA product code for ROUND WINDOW E-CATH is ETD.

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 Neuro-Biometrix, 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.

K965115ROUND WINDOW CATH

Related Devices (Code: ETD)

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.

K252436Tula Tympanostomy Tube Delivery DeviceTusker Medical, Inc.K250256Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))Aventamed DacK232702Solo+ Tympanostomy Tube Device (TTD)Aventamed DacK233658Biowy Tym Tube (TT)Biowy CorporationK232059Tympanostomy TubesGrace Medical, Inc.K221254Hummingbird Tympanostomy Tube SystemPreceptis Medical, 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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