Automatic Spirometer ST-200
FDA 510(k) K832433 · Future Impex Corp.
510(k) numberK832433
Submission
- Device name
- Automatic Spirometer ST-200
- Applicant
- Future Impex Corp.
Mchenry, IL, US - Received
- July 22, 1983
- Decision date
- September 29, 1983
- 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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More from Vitalograph Ireland, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K861487 | ST-90 Spiro AnalizerBTY · Traditional | 06/23/1986SE |
| K854687 | Erma Hb-Meter Model 303NKHG · Traditional | 06/04/1986SE |
| K854686 | TE-25 Coaguro MeterJBP · Traditional | 06/04/1986SE |
| K854685 | DIGITAL-9 Key Leucocyte CounterGKM · Traditional | 04/04/1986SE |
| K854678 | Erma PC-602 PC-603 Blood Cell CounterGKL · Traditional | 02/24/1986SE |
| K854677 | Erma PC-604 Blood Cell CounterGKL · Traditional | 02/24/1986SE |
| K854679 | PHOTIC-100 SpectrophotometerJJQ · Traditional | 02/20/1986SE |
| K843934 | Model {M-102 I-Channel Electro Cardiograph UnitDPS · Traditional | 11/20/1984SE |
| K843984 | PM-80 PulmotesterBZG · Traditional | 10/24/1984SE |
| K843700 | ST-200A W/Maximal Voluntary Ventillat- · Traditional | 10/24/1984SE |
Questions and answers
When was Automatic Spirometer ST-200 cleared by the FDA?
Automatic Spirometer ST-200 (K832433) received a 510(k) decision of Substantially Equivalent on September 29, 1983, 69 days after the submission was received.
What is the product code of K832433?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.