Flutter D
FDA 510(k) K972859 · Bradstreet Clinical Research Assoc., Inc.
510(k) numberK972859
Submission
- Device name
- Flutter D
- Applicant
- Bradstreet Clinical Research Assoc., Inc.
Brunswick, NJ, US - Received
- August 4, 1997
- Decision date
- June 5, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| K173603 | Monarch Airway Clearance SystemBYI · Traditional | Hill-Rom Holdings, Inc. | 10/24/2018SE |
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Questions and answers
When was Flutter D cleared by the FDA?
Flutter D (K972859) received a 510(k) decision of Substantially Equivalent on June 5, 1998, 305 days after the submission was received.
What is the product code of K972859?
The FDA product code is BYI – Percussor, Powered-Electric, a Class II (moderate risk) device regulated under 21 CFR 868.5665.