Downs Adjustable Flow Generator
FDA 510(k) K831503 · Vital Signs, Inc.
510(k) numberK831503
Submission
- Device name
- Downs Adjustable Flow Generator
- Applicant
- Vital Signs, Inc.
East Rutherford, NJ, US - Received
- May 11, 1983
- Decision date
- September 12, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BYE – Attachment, Breathing, Positive End Expiratory Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5965
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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Questions and answers
When was Downs Adjustable Flow Generator cleared by the FDA?
Downs Adjustable Flow Generator (K831503) received a 510(k) decision of Substantially Equivalent on September 12, 1983, 124 days after the submission was received.
What is the product code of K831503?
The FDA product code is BYE – Attachment, Breathing, Positive End Expiratory Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.5965.