Hand Percussor Cup #65210
FDA 510(k) K802646 · B & F Medical Products, Inc.
510(k) numberK802646
Submission
- Device name
- Hand Percussor Cup #65210
- Applicant
- B & F Medical Products, Inc.
Mchenry, IL, US - Received
- October 24, 1980
- Decision date
- November 12, 1980
- 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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| K861054 | Disposable Rescue Breathing DeviceCAE · Traditional | 04/09/1986SE |
| K853004 | Portable Oxygen UnitCAW · Traditional | 08/29/1985SE |
| K843691 | Portable Oxygen UnitCAW · Traditional | 11/07/1984SE |
| K823532 | Stock #64091-PEDIATRIC Oxygen MaskBYG · Traditional | 01/05/1983SE |
| K811404 | TravelaireCCQ · Traditional | 06/09/1981SE |
| K802644 | Emerg. Oxygen Kit #65350 & #65399 CaseCAN · Traditional | 12/22/1980SE |
Questions and answers
When was Hand Percussor Cup #65210 cleared by the FDA?
Hand Percussor Cup #65210 (K802646) received a 510(k) decision of Substantially Equivalent on November 12, 1980, 19 days after the submission was received.
What is the product code of K802646?
The FDA product code is BYI – Percussor, Powered-Electric, a Class II (moderate risk) device regulated under 21 CFR 868.5665.