Respirex 2
FDA 510(k) K900754 · Diemolding Corp.
510(k) numberK900754
Submission
- Device name
- Respirex 2
- Applicant
- Diemolding Corp.
Canastota, NY, US - Received
- February 16, 1990
- Decision date
- March 15, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BWF – Spirometer, Therapeutic (Incentive)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5690
- Specialty
- Anesthesiology
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| K192000 | D R Burton OxyPAPBWF · Traditional | D R Burton Healthcare, LLC | 02/19/2020SE |
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| K961455 | Medshield/AerochamberCCQ · Traditional | 07/25/1996SE |
| K902713 | Access. Kit for the Biosurge Synchronous AutotransCAC · Traditional | 07/25/1990SE |
| K902114 | Cuff-Mate 2 Endotracheal Cuff Inflator & MonitorBSK · Traditional | 07/18/1990SE |
| K893791 | Breathing MouthpieceBYP · Traditional | 06/23/1989SE |
| K781759 | RescalBZA · Traditional | 11/27/1978SE |
| K780750 | O2 ConnectorCAN · Traditional | 07/27/1978SE |
| K770369 | Vacon TMCBD · Traditional | 03/01/1977SE |
| K760931 | I.V. Drip Monitor Alarm Device, MonifloFLN · Traditional | 01/05/1977SE |
| K760636 | OrthomixJDZ · Traditional | 10/05/1976SE |
Questions and answers
When was Respirex 2 cleared by the FDA?
Respirex 2 (K900754) received a 510(k) decision of Substantially Equivalent on March 15, 1990, 27 days after the submission was received.
What is the product code of K900754?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.