Neoguard Chest Percussor
FDA 510(k) K853965 · Cas Medical Systems, Inc.
510(k) numberK853965
Submission
- Device name
- Neoguard Chest Percussor
- Applicant
- Cas Medical Systems, Inc.
Branford, CT, US - Received
- September 26, 1985
- Decision date
- December 3, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BYI – Percussor, Powered-Electric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5665
- Specialty
- Anesthesiology
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Questions and answers
When was Neoguard Chest Percussor cleared by the FDA?
Neoguard Chest Percussor (K853965) received a 510(k) decision of Substantially Equivalent on December 3, 1985, 68 days after the submission was received.
What is the product code of K853965?
The FDA product code is BYI – Percussor, Powered-Electric, a Class II (moderate risk) device regulated under 21 CFR 868.5665.