Cannulae, Plastic Disposable Nasal

FDA 510(k) K760218 · Manner Medical Products

Substantially Equivalent

510(k) numberK760218

Submission

Device name
Cannulae, Plastic Disposable Nasal
Applicant
Manner Medical Products
Mchenry, IL, US
Received
July 12, 1976
Decision date
August 3, 1976
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CAT – Cannula, Nasal, Oxygen
Device class
Class I (low risk)
Regulation
21 CFR 868.5340
Specialty
Anesthesiology

Other 510(k)s with product code CAT

510(k)DeviceApplicantDecision
K011125Nasal Cannula, with and Without Supply Tubing, and Other Similar Nasal Cannula…CAT · Traditional Hudson Respiratory Care, Inc.06/13/2001SE
K935533Nasal CannulaCAT · Traditional Puritas Health Care, Inc.02/03/1994SE
K9223974 Sure TM Nasal Oxygen CannulaCAT · Traditional Boston Pacific Medical, Inc.03/18/1993SE
K921496Skin Saver(Tm) Tubing Holder, Model 1921 ModifiedCAT · Traditional Alpine Specialties, Inc.08/14/1992SE
K920573Cannula Nasal OxygenCAT · Traditional B & F Medical Products, Inc.08/11/1992SE
K913421Nasal Oxygen Cannula, 81585, 81587 & 81589CAT · Traditional Specialty Packaging Producs, Inc.10/18/1991SE
K912197Skin Saver(Tm) Tubing Holder, Model 467CAT · Traditional Alpine Specialties, Inc.08/20/1991SE
K911740Salter Labs Neonatal Nasal Oxygen CannulaCAT · Traditional Salter Labs07/24/1991SE
K902420Catheter, Nasal, OxygenCAT · Traditional Gainor Medical Europe, Ltd.04/17/1991SE
K896036The Comfortable CannulaCAT · Traditional Comfortable Concepts Corp.11/17/1989SE

More from Comfortable Concepts Corp.

510(k)DeviceDecision
K760221I.P.P.B., Dis. W/Manifold/NebulizerCBO · Traditional 08/03/1976SE
K760220Tubing, Single Use Oxygen SupplyBYX · Traditional 08/03/1976SE
K760219Maska, Oxygen Vinyl D-Sp. Single UseBYG · Traditional 08/03/1976SE

Questions and answers

When was Cannulae, Plastic Disposable Nasal cleared by the FDA?

Cannulae, Plastic Disposable Nasal (K760218) received a 510(k) decision of Substantially Equivalent on August 3, 1976, 22 days after the submission was received.

What is the product code of K760218?

The FDA product code is CAT – Cannula, Nasal, Oxygen, a Class I (low risk) device regulated under 21 CFR 868.5340.