Nose Clip

FDA 510(k) K760461 · Inspiron Corp.

Substantially Equivalent

510(k) numberK760461

Submission

Device name
Nose Clip
Applicant
Inspiron Corp.
Mchenry, IL, US
Received
August 18, 1976
Decision date
August 26, 1976
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BXJ – Clip, Nose
Device class
Class I (low risk)
Regulation
21 CFR 868.6225
Specialty
Anesthesiology

Other 510(k)s with product code BXJ

510(k)DeviceApplicantDecision
K853578Medipart Dispos. Nose Clip MP-2001BXJ · Traditional Medipart Jerry Alexander10/29/1985SE
K810339Noseclip #6118BXJ · Traditional Todd Industries, Inc.03/17/1981SE
K770015Noseclip for Resp. Care & Pulmon. Func.BXJ · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic03/16/1977SE

More from Bd Becton Dickinson Vacutainer Systems Preanalytic

510(k)DeviceDecision
K860838Inspiron Double Swivel Trach AdapterBZA · Traditional 04/09/1986SE
K850346Oxygen ConcentratorCAW · Traditional 02/04/1985SE
K843932Vapor-Phase Humidifier Sys-AdvancedBTT · Traditional 10/18/1984SE
K840935Manual Resuscitation SystemBTM · Traditional 04/05/1984SE
K841158Nebulo 28 Nebulizer KitBTT · Traditional 03/30/1984SE
K840418Inspiratory/Expiratory Muscle ExercisBWF · Traditional 02/17/1984SE
K834290Inspiron Liquid Oxygen SystemBYJ · Traditional 02/04/1984SE
K772072Manifold & Nebu. for Doub. Line Mach.CAF · Traditional 11/15/1977SE
K772071Manifold & Nebu. for Single Line Mach.CAF · Traditional 11/15/1977SE
K772070Ventilator Setup, VolumeCAF · Traditional 11/15/1977SE

Questions and answers

When was Nose Clip cleared by the FDA?

Nose Clip (K760461) received a 510(k) decision of Substantially Equivalent on August 26, 1976, 8 days after the submission was received.

What is the product code of K760461?

The FDA product code is BXJ – Clip, Nose, a Class I (low risk) device regulated under 21 CFR 868.6225.