Cmd/Dlco Diagnostic Spirometer
FDA 510(k) K911358 · Spirometrics, Inc.
510(k) numberK911358
Submission
- Device name
- Cmd/Dlco Diagnostic Spirometer
- Applicant
- Spirometrics, Inc.
Auburn, ME, US - Received
- March 28, 1991
- Decision date
- July 22, 1991
- 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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| K181912 | Ascent Cardiorespiratory Diagnostic SoftwareBTY · Traditional | Medical Graphics Corporation | 04/12/2019SE |
| K173937 | SpiroSphereBTY · Traditional | Eresearchtechnology GmbH | 02/15/2019SE |
More from Eresearchtechnology GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K915059 | Peak Flow MonitorBZH · Traditional | 07/27/1992SE |
| K900322 | CO/CMD-1CCJ · Traditional | 04/30/1990SE |
| K901057 | Spirometrics Model 2600 Miro SpirometerBZG · Traditional | 04/03/1990SE |
| K900673 | Serial FlowBZG · Traditional | 04/03/1990SE |
| K884464 | Spirometrics Model 2200 SM200 Flow SensorJAX · Traditional | 01/19/1989SE |
| K884465 | Spirometrics Model 2141 Spiro-Filter(Tm)CAH · Traditional | 11/09/1988SE |
| K863953 | Spirometrics Model 2500 Flowmate(Tm)BZM · Traditional | 01/15/1987SE |
| K850045 | Spirometrics 2453 & Smi IIIBTY · Traditional | 02/14/1985SE |
| K844333 | Spirometrics 2451 & Smi IBZG · Traditional | 11/20/1984SE |
| K831497 | Spirometrics Breon 2400 & Smi 2400BZG · Traditional | 06/24/1983SE |
Questions and answers
When was Cmd/Dlco Diagnostic Spirometer cleared by the FDA?
Cmd/Dlco Diagnostic Spirometer (K911358) received a 510(k) decision of Substantially Equivalent on July 22, 1991, 116 days after the submission was received.
What is the product code of K911358?
The FDA product code is BTY – Calculator, Predicted Values, Pulmonary Function, a Class II (moderate risk) device regulated under 21 CFR 868.1890.