1 Video Tape Recorder Model BK-224 H
FDA 510(k) K892934 · Perkins Mfg. Co.
510(k) numberK892934
Submission
- Device name
- 1 Video Tape Recorder Model BK-224 H
- Applicant
- Perkins Mfg. Co.
Dallas, TX, US - Received
- April 21, 1989
- Decision date
- July 20, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K251004 | Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)OXO · Traditional | Hefei Chimed Intelligent Machine Co., Ltd. | 11/06/2025SE |
| K250587 | Orthoscan TAU Mini C-ArmOXO · Special | Ziehm-Orthoscan, Inc. | 07/02/2025SE |
| K243452 | Orthoscan VERSA Mini C-ArmOXO · Traditional | Ziehm-Orthoscan, Inc. | 01/14/2025SE |
| K240828 | OEC One ASDOXO · Traditional | Ge Hualun Medical Systems Co. , Ltd. | 12/27/2024SE |
| K233669 | Oec 3DOXO · Traditional | Ge Oec Medical Systems, Inc. | 03/28/2024SE |
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| K203346 | Oec 3DOXO · Traditional | Ge Oec Medical Systems, Inc. | 03/05/2021SE |
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| K910384 | Video Annotator Model PK2310JAA · Traditional | 04/16/1991SE |
| K904986 | Programmable Video Controller Model PK2060JAA · Traditional | 12/04/1990SE |
| K904540 | Video System Interface ModelsIZI · Traditional | 10/26/1990SE |
| K896615 | Cine Camera Control Model PK2037IZJ · Traditional | 01/04/1990SE |
| K895500 | Patient Positioning AccessoriesIYE · Traditional | 11/06/1989SE |
Questions and answers
When was 1 Video Tape Recorder Model BK-224 H cleared by the FDA?
1 Video Tape Recorder Model BK-224 H (K892934) received a 510(k) decision of Substantially Equivalent on July 20, 1989, 90 days after the submission was received.
What is the product code of K892934?
The FDA product code is OXO – Image-Intensified Fluoroscopic X-Ray System, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1650.