Turboaire Challanger Environmental Air Controller
FDA 510(k) K843996 · Equilibrated Bio Systems, Inc.
510(k) numberK843996
Submission
- Device name
- Turboaire Challanger Environmental Air Controller
- Applicant
- Equilibrated Bio Systems, Inc.
Melville, NY, US - Received
- October 11, 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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| 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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| K790410 | Adult Zee-FrameJAY · Traditional | 03/22/1979SE |
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Questions and answers
When was Turboaire Challanger Environmental Air Controller cleared by the FDA?
Turboaire Challanger Environmental Air Controller (K843996) received a 510(k) decision of Substantially Equivalent on November 20, 1984, 40 days after the submission was received.
What is the product code of K843996?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.