Microair 3500
FDA 510(k) K914674 · Gsi Development Co.
510(k) numberK914674
Submission
- Device name
- Microair 3500
- Applicant
- Gsi Development Co.
Carmel, NY, US - Received
- October 18, 1991
- Decision date
- November 22, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 Microair 3500 cleared by the FDA?
Microair 3500 (K914674) received a 510(k) decision of Substantially Equivalent on November 22, 1991, 35 days after the submission was received.
What is the product code of K914674?
The FDA product code is IOQ – Bed, Flotation Therapy, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5170.