Flex-Cup Percussor
FDA 510(k) K892862 · Life Design Systems, Inc.
510(k) numberK892862
Submission
- Device name
- Flex-Cup Percussor
- Applicant
- Life Design Systems, Inc.
Carrollton, TX, US - Received
- April 18, 1989
- Decision date
- May 25, 1989
- 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 |
|---|---|---|
| K913714 | Modification Manual Pulmon Resuscitor/Pulmanex(Tm)BTM · Traditional | 12/01/1992SE |
| K885313 | Humidi-Flex TMBYD · Traditional | 10/11/1989SE |
| K893030 | Child Size - Filter Flex (TM)CAH · Traditional | 09/18/1989SE |
| K892221 | Pulmonary Resuscitator, ModificationBTM · Traditional | 05/18/1989SE |
| K890011 | Oxygen Connector and Oxygen Delivery TubingBZO · Traditional | 03/20/1989SE |
| K890108 | Modified Cushion-Flex(Tm)BSJ · Traditional | 01/24/1989SE |
| K884387 | Cushion Flex(Tm)BSJ · Traditional | 11/17/1988SE |
| K884068 | Pulmanex TM (Neo-Natal Size)BTM · Traditional | 11/16/1988SE |
| K873179 | Heater Wire Breathing CircuitBZE · Traditional | 03/31/1988SE |
| K863857 | Pulse-OxDQA · Traditional | 10/07/1987SE |
Questions and answers
When was Flex-Cup Percussor cleared by the FDA?
Flex-Cup Percussor (K892862) received a 510(k) decision of Substantially Equivalent on May 25, 1989, 37 days after the submission was received.
What is the product code of K892862?
The FDA product code is BYI – Percussor, Powered-Electric, a Class II (moderate risk) device regulated under 21 CFR 868.5665.