Salter Labs 3000 Series Percussors
FDA 510(k) K863658 · Salter Labs
510(k) numberK863658
Submission
- Device name
- Salter Labs 3000 Series Percussors
- Applicant
- Salter Labs
Arvin, CA, US - Received
- September 18, 1986
- Decision date
- October 6, 1986
- 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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| K261389 | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)CCL · Traditional | 07/30/2026SE |
| K190878 | Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and…BTR · Traditional | 01/10/2020SE |
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| K151874 | BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor…MNR · Traditional | 04/15/2016SE |
| K151506 | Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaNFB · Traditional | 03/11/2016SE |
| K151421 | Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula…CCK · Traditional | 03/10/2016SE |
| K143700 | CPAP CannulaideBZD · Traditional | 08/05/2015SE |
| K142416 | Luma WrapPDH · Traditional | 06/12/2015SE |
| K092685 | Pneumotherml, Model: 5800BZQ · Special | 11/24/2009SE |
| K051313 | Bi-Naps Nasal Airflow and Snore TransducerMNR · Traditional | 09/15/2005SE |
Questions and answers
When was Salter Labs 3000 Series Percussors cleared by the FDA?
Salter Labs 3000 Series Percussors (K863658) received a 510(k) decision of Substantially Equivalent on October 6, 1986, 18 days after the submission was received.
What is the product code of K863658?
The FDA product code is BYI – Percussor, Powered-Electric, a Class II (moderate risk) device regulated under 21 CFR 868.5665.