Celltrak-B
FDA 510(k) K834585 · R&D Systems, Inc.
510(k) numberK834585
Submission
- Device name
- Celltrak-B
- Applicant
- R&D Systems, Inc.
Mchenry, IL, US - Received
- December 29, 1983
- Decision date
- May 2, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRZ – Device, Patient Transfer, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6775
- Specialty
- General Hospital
Other 510(k)s with product code FRZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K121929 | Zephyr 'X-Series Patient Transfer SledFRZ · Traditional | Diacor, Inc. | 01/17/2013SE |
| K910830 | InvaliftFRZ · Traditional | American Invalift Corp. | 06/09/1992SE |
| K841728 | Lci Medical Inc Air/PalFRZ · Traditional | Lehigh Consolidated Industries | 06/05/1984SE |
| K840796 | Tender Lifting CareFRZ · Traditional | Lancer Assoc. | 04/20/1984SE |
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Questions and answers
When was Celltrak-B cleared by the FDA?
Celltrak-B (K834585) received a 510(k) decision of Substantially Equivalent on May 2, 1984, 125 days after the submission was received.
What is the product code of K834585?
The FDA product code is FRZ – Device, Patient Transfer, Powered, a Class II (moderate risk) device regulated under 21 CFR 880.6775.