Prism
FDA 510(k) K932480 · Bio Clinic Co.
510(k) numberK932480
Submission
- Device name
- Prism
- Applicant
- Bio Clinic Co.
Ontario, CA, US - Received
- May 24, 1993
- Decision date
- July 21, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K970636 | Totalcare., Modular Therapy System (MTS)IOQ · Traditional | Hill-Rom, Inc. | 08/26/1997SE |
| K964873 | Silkair Low Airloss TherapyIOQ · Traditional | Hill-Rom, Inc. | 07/03/1997SE |
| K970295 | Flexicair Exlipse PlusIOQ · Traditional | Hill-Rom, Inc. | 05/16/1997SE |
| K943433 | Total Contact Seat Ripple SystemIOQ · Traditional | Numotech, Inc. | 07/31/1995SE |
| K951001 | Flexicair ExlipseIOQ · Traditional | Hill-Rom, Inc. | 06/27/1995SE |
More from Hill-Rom, Inc.
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|---|---|---|
| K930791 | American Power Conversions, Back-Ups 600FMF · Traditional | 08/06/1993SE |
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| K921958 | Elisa Tube TSH TestJLW · Traditional | 07/02/1992SE |
| K922140 | Orthoderm Convertible IIIOQ · Traditional | 05/27/1992SE |
| K921212 | Mirco Elisa HPL Test KitJHI · Traditional | 05/07/1992SE |
| K921211 | Now Pregnancy Test KitJHI · Traditional | 05/07/1992SE |
| K920921 | Elisa Tube Prolactin Test KitCFT · Traditional | 04/08/1992SE |
| K920920 | Elisa Tube LH Test KitCEP · Traditional | 04/08/1992SE |
| K920918 | TMB Chromogen/Substrate Reagent SetJHI · Traditional | 04/07/1992SE |
| K920917 | Elisa Tube FSH Test Kit Enzyme Linked Immun. AssayCGJ · Traditional | 03/26/1992SE |
Questions and answers
When was Prism cleared by the FDA?
Prism (K932480) received a 510(k) decision of Substantially Equivalent on July 21, 1993, 58 days after the submission was received.
What is the product code of K932480?
The FDA product code is IOQ – Bed, Flotation Therapy, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5170.