Cushion-Flex TM

FDA 510(k) K843169 · Life Design Systems, Inc.

Substantially Equivalent

510(k) numberK843169

Submission

Device name
Cushion-Flex TM
Applicant
Life Design Systems, Inc.
Mchenry, IL, US
Received
August 13, 1984
Decision date
August 20, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BSJ – Mask, Gas, Anesthetic
Device class
Class I (low risk)
Regulation
21 CFR 868.5550
Specialty
Anesthesiology

Other 510(k)s with product code BSJ

510(k)DeviceApplicantDecision
K163277SuperNO2VA DeviceBSJ · Traditional Revolutionary Medical Devices, Inc.10/13/2017SE
K953107Anesthesia/Respiratory Face MaskBSJ · Traditional Medical Marketing Concepts08/15/1995SE
K953295Anesthesia Face MaskBSJ · Traditional Mallinckrodt Medical08/11/1995SE
K952689Brigam Medical Disposable Anesthesia/Respiratory Face MaskBSJ · Traditional Owens-Brigam Medical Co.07/11/1995SE
K951043Air-Soft-Disposable, Anesthesisa/Respiratory Face MaskBSJ · Traditional Promedic, Inc.06/07/1995SE
K950771Disposable Adhesive Face MaskBSJ · Traditional Advanced Warming Systems, Inc.03/10/1995SE
K945894Mask, Gas, AnestheticBSJ · Traditional Hans Rudolph, Inc.01/27/1995SE
K945440Disposable, Anesthesia/Respiratory Face MaskBSJ · Traditional Fvtnks11/08/1994SE
K944157Disposable, Preformed Face MaskBSJ · Traditional Meridian Medical Systems, Inc.10/03/1994SE
K932147Non Conductive Anesthesia Face Mask,SiliconeBSJ · Traditional Hans Rudolph, Inc.08/20/1993SE

More from Hans Rudolph, Inc.

510(k)DeviceDecision
K913714Modification Manual Pulmon Resuscitor/Pulmanex(Tm)BTM · Traditional 12/01/1992SE
K885313Humidi-Flex TMBYD · Traditional 10/11/1989SE
K893030Child Size - Filter Flex (TM)CAH · Traditional 09/18/1989SE
K892862Flex-Cup PercussorBYI · Traditional 05/25/1989SE
K892221Pulmonary Resuscitator, ModificationBTM · Traditional 05/18/1989SE
K890011Oxygen Connector and Oxygen Delivery TubingBZO · Traditional 03/20/1989SE
K890108Modified Cushion-Flex(Tm)BSJ · Traditional 01/24/1989SE
K884387Cushion Flex(Tm)BSJ · Traditional 11/17/1988SE
K884068Pulmanex TM (Neo-Natal Size)BTM · Traditional 11/16/1988SE
K873179Heater Wire Breathing CircuitBZE · Traditional 03/31/1988SE

Questions and answers

When was Cushion-Flex TM cleared by the FDA?

Cushion-Flex TM (K843169) received a 510(k) decision of Substantially Equivalent on August 20, 1984, 7 days after the submission was received.

What is the product code of K843169?

The FDA product code is BSJ – Mask, Gas, Anesthetic, a Class I (low risk) device regulated under 21 CFR 868.5550.