Diss Female Air Adaptor

FDA 510(k) K813235 · Timeter Instrument Corp.

Substantially Equivalent

510(k) numberK813235

Submission

Device name
Diss Female Air Adaptor
Applicant
Timeter Instrument Corp.
Mchenry, IL, US
Received
November 17, 1981
Decision date
December 8, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BYK – Tent, Oxygen, Electrically Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5710
Specialty
Anesthesiology
Life-sustaining
Yes

Other 510(k)s with product code BYK

510(k)DeviceApplicantDecision
K941547Cam 4 Thermoelectric Child/Adult Mist TentBYK · Traditional Allied Healthcare Products, Inc.03/01/1995SE
K882817Lung Diffusion Gas MixtureBYK · Traditional Swisco, Inc.08/15/1988SE

More from Swisco, Inc.

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K871603Criterion II & Iia Oxygen ConcentratorsCAW · Traditional 08/13/1987SE
K864836L.A.P. SpirometerBTY · Traditional 03/06/1987SE
K834274Criterion ICAW · Traditional 04/13/1984SE
K823775Bordon Gage Regulator #BgCCN · Traditional 01/14/1983SE
K822746RT-200 Calibration AnalyzerBXX · Traditional 10/13/1982SE
K812766PCS-5 AccessoriesBTI · Traditional 12/17/1981SE
K813234Ohio Air AdaptorBYX · Traditional 12/08/1981SE
K812767Sniff Air Compressor #SF-6BTI · Traditional 11/27/1981SE

Questions and answers

When was Diss Female Air Adaptor cleared by the FDA?

Diss Female Air Adaptor (K813235) received a 510(k) decision of Substantially Equivalent on December 8, 1981, 21 days after the submission was received.

What is the product code of K813235?

The FDA product code is BYK – Tent, Oxygen, Electrically Powered, a Class II (moderate risk) device regulated under 21 CFR 868.5710.