Adult-Pediatric Transport System
FDA 510(k) K955766 · International Biomedical, Inc.
510(k) numberK955766
Submission
- Device name
- Adult-Pediatric Transport System
- Applicant
- International Biomedical, Inc.
Austin, TX, US - Received
- December 20, 1995
- Decision date
- August 7, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FPO – Stretcher, Wheeled
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6910
- Specialty
- General Hospital
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| K103525 | A750I Transport Incubator with Masimo Pluseox, A750I Transport Incubator with Nellor…FPL · Special | 05/11/2011SE |
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Questions and answers
When was Adult-Pediatric Transport System cleared by the FDA?
Adult-Pediatric Transport System (K955766) received a 510(k) decision of Substantially Equivalent on August 7, 1996, 231 days after the submission was received.
What is the product code of K955766?
The FDA product code is FPO – Stretcher, Wheeled, a Class II (moderate risk) device regulated under 21 CFR 880.6910.