L.A.P. Spirometer
FDA 510(k) K864836 · Timeter Instrument Corp.
510(k) numberK864836
Submission
- Device name
- L.A.P. Spirometer
- Applicant
- Timeter Instrument Corp.
Lancaster, PA, US - Received
- December 9, 1986
- Decision date
- March 6, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BTY – Calculator, Predicted Values, Pulmonary Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1890
- Specialty
- Anesthesiology
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| K223629 | SpiroSphere, SpiroSphereECG, CardioSphereBTY · Traditional | Eresearchtechnology GmbH | 05/28/2024SE |
| K231561 | Pulmonary Function Tester, Model: A9BTY · Traditional | Guangzhou Homesun Medical Technology Co., Ltd. | 02/21/2024SE |
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| K190800 | Cosmed Q-NRG / Q-NRG+ Portable Metabolic MonitorsBTY · Traditional | Cosmed Srl | 02/06/2020SE |
| K181912 | Ascent Cardiorespiratory Diagnostic SoftwareBTY · Traditional | Medical Graphics Corporation | 04/12/2019SE |
| K173937 | SpiroSphereBTY · Traditional | Eresearchtechnology GmbH | 02/15/2019SE |
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| K875075 | RT-200 Computer InterfaceBXX · Traditional | 04/21/1988SE |
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| K871603 | Criterion II & Iia Oxygen ConcentratorsCAW · Traditional | 08/13/1987SE |
| K834274 | Criterion ICAW · Traditional | 04/13/1984SE |
| K823775 | Bordon Gage Regulator #BgCCN · Traditional | 01/14/1983SE |
| K822746 | RT-200 Calibration AnalyzerBXX · Traditional | 10/13/1982SE |
| K812766 | PCS-5 AccessoriesBTI · Traditional | 12/17/1981SE |
| K813235 | Diss Female Air AdaptorBYK · Traditional | 12/08/1981SE |
| K813234 | Ohio Air AdaptorBYX · Traditional | 12/08/1981SE |
| K812767 | Sniff Air Compressor #SF-6BTI · Traditional | 11/27/1981SE |
Questions and answers
When was L.A.P. Spirometer cleared by the FDA?
L.A.P. Spirometer (K864836) received a 510(k) decision of Substantially Equivalent on March 6, 1987, 87 days after the submission was received.
What is the product code of K864836?
The FDA product code is BTY – Calculator, Predicted Values, Pulmonary Function, a Class II (moderate risk) device regulated under 21 CFR 868.1890.