Cushion-Flex Tm-Cpap Face Mask
FDA 510(k) K854458 · Life Design Systems, Inc.
510(k) numberK854458
Submission
- Device name
- Cushion-Flex Tm-Cpap Face Mask
- Applicant
- Life Design Systems, Inc.
Milwaukee, WI, US - Received
- November 6, 1985
- Decision date
- January 15, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BYE – Attachment, Breathing, Positive End Expiratory Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5965
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| 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 |
Questions and answers
When was Cushion-Flex Tm-Cpap Face Mask cleared by the FDA?
Cushion-Flex Tm-Cpap Face Mask (K854458) received a 510(k) decision of Substantially Equivalent on January 15, 1986, 70 days after the submission was received.
What is the product code of K854458?
The FDA product code is BYE – Attachment, Breathing, Positive End Expiratory Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.5965.