CTC 30, 40, 1 Liquid Oxygen Liters

FDA 510(k) K860738 · Cryodyne Technologies, Inc.

Substantially Equivalent

510(k) numberK860738

Submission

Device name
CTC 30, 40, 1 Liquid Oxygen Liters
Applicant
Cryodyne Technologies, Inc.
Riviera Beach, FL, US
Received
February 27, 1986
Decision date
August 6, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BYJ – Unit, Liquid-Oxygen, Portable
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5655
Specialty
Anesthesiology

Other 510(k)s with product code BYJ

510(k)DeviceApplicantDecision
K130068Dismounted Medical & Supplemental Oxygen System (Dmos)BYJ · Traditional Essex Industries, Inc. D/B/A Essex Cryogenics of M07/19/2013SE
K113767Mounted Medical Oxygen SystemBYJ · Traditional Essex Industries, Inc.06/29/2012SE
K103324Precision Liquid Oxygen SystemBYJ · Traditional Precision Medical, Inc.04/21/2011SE
K101272Mass Oxygen Distribution System (Mods) Model 10C-0061-3BYJ · Traditional Essex Industries, Inc.08/20/2010SE
K081779GOLOX-93BYJ · Traditional Respironics, Inc.09/19/2008SE
K080023Modification to: SpiritBYJ · Special Caire, Inc.06/16/2008SE
K072723Respironics GoloxBYJ · Traditional Respironics, Inc.03/20/2008SE
K072011Copd Liquid Oxygen Portable, Model 300PBYJ · Traditional Copd Partners, Inc.10/18/2007SE
K071581Backpack Medical Oxygen SystemBYJ · Traditional Essex Cryogenics of Missouri, Inc.07/11/2007SE
K050153Spirit, Model HasBYJ · Traditional Caire, Inc.04/15/2005SE

More from Caire, Inc.

510(k)DeviceDecision
K926464L.C.S.3000GEH · Traditional 08/24/1993SE
K932520Calibration GasBXK · Traditional 08/19/1993SE
K881465Cryobiological FreezerKSP · Traditional 04/21/1988SE
K881467Microscope Stage HeaterKEJ · Traditional 04/18/1988SE
K881466Cell-Culture ShakerKJB · Traditional 04/18/1988SE

Questions and answers

When was CTC 30, 40, 1 Liquid Oxygen Liters cleared by the FDA?

CTC 30, 40, 1 Liquid Oxygen Liters (K860738) received a 510(k) decision of Substantially Equivalent on August 6, 1986, 160 days after the submission was received.

What is the product code of K860738?

The FDA product code is BYJ – Unit, Liquid-Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5655.