Vitalograph Data Storage Spirometer
FDA 510(k) K930085 · Vitalograph , Ltd.
510(k) numberK930085
Submission
- Device name
- Vitalograph Data Storage Spirometer
- Applicant
- Vitalograph , Ltd.
Lenexa, KS, US - Received
- January 7, 1993
- Decision date
- July 26, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| K222982 | Virtus Metabolic MonitorBTY · Traditional | Virtus Technology Aps | 06/23/2023SE |
| K221030 | Model 9100 PFT/DICOBTY · Traditional | Vitalograph Ireland, Ltd. | 07/15/2022SE |
| K202754 | MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSUBTY · Traditional | Eresearchtechnology GmbH | 01/28/2021SE |
| 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 |
More from Eresearchtechnology GmbH
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|---|---|---|
| K253293 | VitaloJAK Clinic (Model 7100)DSH · Special | 12/03/2025SE |
| K000599 | Vitalograph Base StationBZG · Traditional | 09/08/2000SE |
| K991412 | Vitalograph MicroBZH · Traditional | 02/04/2000SE |
| K943678 | Electronic Flow MeterBZH · Traditional | 12/14/1995SE |
| K950854 | Vitalograph 2110 Software InterfaceDSH · Traditional | 10/12/1995SE |
| K946075 | Vitalograph Model 2120BZG · Traditional | 08/04/1995SE |
| K942779 | Disposable Bacteriological FilterBZG · Traditional | 07/13/1994SE |
| K925085 | Escort SpirometerBZG · Traditional | 08/12/1993SE |
| K912412 | Vitalograph Spirotrac IIIBZG · Traditional | 10/15/1991SE |
| K893665 | Aerosol Inhalation MonitorBWF · Traditional | 08/21/1989SE |
Questions and answers
When was Vitalograph Data Storage Spirometer cleared by the FDA?
Vitalograph Data Storage Spirometer (K930085) received a 510(k) decision of Substantially Equivalent on July 26, 1993, 200 days after the submission was received.
What is the product code of K930085?
The FDA product code is BTY – Calculator, Predicted Values, Pulmonary Function, a Class II (moderate risk) device regulated under 21 CFR 868.1890.