Spirometrics 2453 & Smi III
FDA 510(k) K850045 · Spirometrics, Inc.
510(k) numberK850045
Submission
- Device name
- Spirometrics 2453 & Smi III
- Applicant
- Spirometrics, Inc.
Andover, MA, US - Received
- January 7, 1985
- Decision date
- February 14, 1985
- 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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More from Eresearchtechnology GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K915059 | Peak Flow MonitorBZH · Traditional | 07/27/1992SE |
| K911358 | Cmd/Dlco Diagnostic SpirometerBTY · Traditional | 07/22/1991SE |
| 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 |
| K844333 | Spirometrics 2451 & Smi IBZG · Traditional | 11/20/1984SE |
| K831497 | Spirometrics Breon 2400 & Smi 2400BZG · Traditional | 06/24/1983SE |
Questions and answers
When was Spirometrics 2453 & Smi III cleared by the FDA?
Spirometrics 2453 & Smi III (K850045) received a 510(k) decision of Substantially Equivalent on February 14, 1985, 38 days after the submission was received.
What is the product code of K850045?
The FDA product code is BTY – Calculator, Predicted Values, Pulmonary Function, a Class II (moderate risk) device regulated under 21 CFR 868.1890.