Spirometrics 2451 & Smi I
FDA 510(k) K844333 · Spirometrics, Inc.
510(k) numberK844333
Submission
- Device name
- Spirometrics 2451 & Smi I
- Applicant
- Spirometrics, Inc.
Andover, MA, US - Received
- November 7, 1984
- Decision date
- November 20, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZG – Spirometer, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1840
- Specialty
- Anesthesiology
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|---|---|---|---|
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| K231416 | Air Next (NVD-02)BZG · Traditional | Nuvoair AB | 01/18/2024SE |
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| K222525 | Alveoair Digital SpirometerBZG · Traditional | Roundworks Technologies Private Limited | 08/28/2023SE |
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| K213754 | SpiroHome Personal, SpiroHome ClinicBZG · Traditional | Inofab Saglik Teknolojileri A.S | 06/12/2023SE |
| K213872 | ComPAS2BZG · Traditional | Morgan Scientific, Inc. | 07/15/2022SE |
| K212938 | Vitalograph Model 6000 AlphaBZG · Traditional | Vitalograph Ireland, Ltd. | 01/26/2022SE |
More from Vitalograph Ireland, Ltd.
| 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 |
| K850045 | Spirometrics 2453 & Smi IIIBTY · Traditional | 02/14/1985SE |
| K831497 | Spirometrics Breon 2400 & Smi 2400BZG · Traditional | 06/24/1983SE |
Questions and answers
When was Spirometrics 2451 & Smi I cleared by the FDA?
Spirometrics 2451 & Smi I (K844333) received a 510(k) decision of Substantially Equivalent on November 20, 1984, 13 days after the submission was received.
What is the product code of K844333?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.