Brentwood Iqmark Digital Spirometer (Includes Disposable Pneumotach Mouthpieces and 3-LITER Calibration Syringe
FDA 510(k) K002499 · Brentwood Medical Technology Corp.
510(k) numberK002499
Submission
- Device name
- Brentwood Iqmark Digital Spirometer (Includes Disposable Pneumotach Mouthpieces and 3-LITER Calibration Syringe
- Applicant
- Brentwood Medical Technology Corp.
Torrance, CA, US - Received
- August 14, 2000
- Decision date
- November 8, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZG – Spirometer, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1840
- Specialty
- Anesthesiology
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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 |
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| K103640 | Midmark IqecgDPS · Traditional | 03/22/2011SE |
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| K052898 | Iqmark Ez StressDPS · Traditional | 03/28/2006SE |
| K031466 | Iqmark Digital HolterMLO · Special | 06/11/2003SE |
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Questions and answers
When was Brentwood Iqmark Digital Spirometer (Includes Disposable Pneumotach Mouthpieces and 3-LITER Calibration Syringe cleared by the FDA?
Brentwood Iqmark Digital Spirometer (Includes Disposable Pneumotach Mouthpieces and 3-LITER Calibration Syringe (K002499) received a 510(k) decision of Substantially Equivalent on November 8, 2000, 86 days after the submission was received.
What is the product code of K002499?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.