Respiratory Exercisor, Volume Pulse
FDA 510(k) K781669 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK781669
Submission
- Device name
- Respiratory Exercisor, Volume Pulse
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Washington, DC, US - Received
- October 3, 1978
- Decision date
- October 23, 1978
- 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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Questions and answers
When was Respiratory Exercisor, Volume Pulse cleared by the FDA?
Respiratory Exercisor, Volume Pulse (K781669) received a 510(k) decision of Substantially Equivalent on October 23, 1978, 20 days after the submission was received.
What is the product code of K781669?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.