Infant Percussor #5534
FDA 510(k) K812803 · Hudson Oxygen Therapy Sales Co.
510(k) numberK812803
Submission
- Device name
- Infant Percussor #5534
- Applicant
- Hudson Oxygen Therapy Sales Co.
Walker, MI, US - Received
- October 6, 1981
- Decision date
- December 3, 1981
- 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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More from Hill-Rom Services Pte, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K902062 | Peep ValveBYE · Traditional | 09/04/1990SE |
| K900783 | Mdi AdaptorCAF · Traditional | 07/18/1990SE |
| K900470 | In-The NebulizerCAF · Traditional | 05/18/1990SE |
| K895589 | Manual ResuscitatorBTM · Traditional | 03/30/1990SE |
| K896136 | Infant C.P.A.P. MonitorCAP · Traditional | 01/09/1990SE |
| K895747 | Ventilarm II Portable Airway Pressure MonitorCAP · Traditional | 10/27/1989SE |
| K895231 | Catalog No. 1755 1S0-NEB, a Filtered NebulizerCAF · Traditional | 10/27/1989SE |
| K890035 | Bacteria FilterCAH · Traditional | 05/05/1989SE |
| K870895 | No. 1552, Valved Venti-CompCBP · Traditional | 05/04/1987SE |
| K871157 | C.P.A.P. Nasal CannulaBZD · Traditional | 04/21/1987SE |
Questions and answers
When was Infant Percussor #5534 cleared by the FDA?
Infant Percussor #5534 (K812803) received a 510(k) decision of Substantially Equivalent on December 3, 1981, 58 days after the submission was received.
What is the product code of K812803?
The FDA product code is BYI – Percussor, Powered-Electric, a Class II (moderate risk) device regulated under 21 CFR 868.5665.