Spiro Analyzer Model ST 250
FDA 510(k) K901308 · Futuremed Div. of Future Impex Corp.
510(k) numberK901308
Submission
- Device name
- Spiro Analyzer Model ST 250
- Applicant
- Futuremed Div. of Future Impex Corp.
Deerpark, NY, US - Received
- March 20, 1990
- Decision date
- July 23, 1990
- 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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| 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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| 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 |
|---|---|---|
| K933511 | Upgraded Spirometer ST-90BTY · Traditional | 02/10/1994SE |
| K933220 | Selector SL 01EWO · Traditional | 11/24/1993SE |
| K933222 | Audiometer Da 323EWO · Traditional | 11/01/1993SE |
| K903017 | Mega-Tens Dual Channel T.E.N.S.GZJ · Traditional | 10/26/1990SE |
| K884972 | Transcoutaneous Electro-Neuro StimulatorGZJ · Traditional | 07/27/1989SE |
| K871421 | Model HL-100 Portable DC Elect. Therapeutic UnitIPF · Traditional | 01/22/1988SE |
| K873817 | Spiro Analyzer ST-300BZG · Traditional | 12/02/1987SE |
| K872044 | Carbon ElectrodeGXY · Traditional | 07/16/1987SE |
| K872045 | Conductivity GelGYB · Traditional | 07/15/1987SE |
| K871913 | Conductivity GelGYB · Traditional | 07/15/1987SE |
Questions and answers
When was Spiro Analyzer Model ST 250 cleared by the FDA?
Spiro Analyzer Model ST 250 (K901308) received a 510(k) decision of Substantially Equivalent on July 23, 1990, 125 days after the submission was received.
What is the product code of K901308?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.