Air Bed & Flotation Dermagard 800 & 900 Systems
FDA 510(k) K882229 · Biologics Intl., Inc.
510(k) numberK882229
Submission
- Device name
- Air Bed & Flotation Dermagard 800 & 900 Systems
- Applicant
- Biologics Intl., Inc.
Indian Rocks Beach, FL, US - Received
- May 20, 1988
- Decision date
- August 16, 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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| K811375 | Bi-Ra Slide TestDHR · Traditional | 06/12/1981SE |
| K811374 | Bi-Crp Latex TestDCN · Traditional | 06/12/1981SE |
| K800605 | Ana Latex Slide TestDHC · Traditional | 04/02/1980SE |
| K791609 | Be-SureJHJ · Traditional | 10/02/1979SE |
| K791607 | Beta-CellJSG · Traditional | 09/24/1979SE |
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Questions and answers
When was Air Bed & Flotation Dermagard 800 & 900 Systems cleared by the FDA?
Air Bed & Flotation Dermagard 800 & 900 Systems (K882229) received a 510(k) decision of Substantially Equivalent on August 16, 1988, 88 days after the submission was received.
What is the product code of K882229?
The FDA product code is IOQ – Bed, Flotation Therapy, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5170.