Add-On to Critical Patient Care Bed
FDA 510(k) K882177 · Cardio Systems, Inc.
510(k) numberK882177
Submission
- Device name
- Add-On to Critical Patient Care Bed
- Applicant
- Cardio Systems, Inc.
Dallas, TX, US - Received
- May 24, 1988
- Decision date
- December 1, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IOQ – Bed, Flotation Therapy, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5170
- Specialty
- Physical Medicine
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Questions and answers
When was Add-On to Critical Patient Care Bed cleared by the FDA?
Add-On to Critical Patient Care Bed (K882177) received a 510(k) decision of Substantially Equivalent on December 1, 1988, 191 days after the submission was received.
What is the product code of K882177?
The FDA product code is IOQ – Bed, Flotation Therapy, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5170.