Model Pcx/Emy 525A Microprocesssor Control X-Ray C
FDA 510(k) K850761 · Medicor USA , Ltd.
510(k) numberK850761
Submission
- Device name
- Model Pcx/Emy 525A Microprocesssor Control X-Ray C
- Applicant
- Medicor USA , Ltd.
Columbus, OH, US - Received
- February 25, 1985
- Decision date
- September 19, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZN – Cart, Emergency, Cardiopulmonary (Excluding Equipment)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.6175
- Specialty
- Anesthesiology
Other 510(k)s with product code BZN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K924373 | Accuflate Accessorie Cart W/Iv Pole and ClampBZN · Traditional | Instrumed, Inc. | 11/25/1992SE |
| K872558 | Cart, Emergency, CardiopulmonaryBZN · Traditional | Nico Metal Products Corp. | 07/24/1987SE |
| K840264 | Servo Cart 170BZN · Traditional | Siemens Elema AB | 02/04/1984SE |
| K832697 | RMP Intubation Equip. Storage TrayBZN · Traditional | Rmp Co. | 12/27/1983SE |
| K832356 | Portable Operat. Rm. Monitors HS30/40BZN · Traditional | Medtel Pty. , Ltd. | 10/28/1983SE |
| K832355 | Crash CartBZN · Traditional | Quinton, Inc. | 10/28/1983SE |
| K772320 | Emergency CartBZN · Traditional | Physio-Control Corp. | 01/03/1978SE |
More from Physio-Control Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K861994 | Model RS-3I Radiographic/Fluroscopic X-Ray SystemKPR · Traditional | 07/18/1986SE |
| K861995 | Model RS-3 Radiographic StandIYB · Traditional | 06/19/1986SE |
| K860025 | Model MS-325 Radiographic X-Ray GeneratorKPR · Traditional | 05/07/1986SE |
| K851358 | Model Bion 2/TYPE 90 Room IonizerFRF · Traditional | 07/01/1985SE |
| K851094 | Model Bion 1/TYPE 1084T Car IonizerFRF · Traditional | 06/19/1985SE |
| K843335 | Floor Mounted X-Ray TubestandIYB · Traditional | 11/27/1984SE |
| K840227 | UROLIX-3 Urological TableIXR · Traditional | 03/23/1984SE |
| K840225 | C-Arm Ceiling Crane FT-2JAA · Traditional | 03/22/1984SE |
| K840226 | Motor Tilted Exam. Table UV-56IXR · Traditional | 03/16/1984SE |
| K823695 | CPM Metabolic MonitorBZL · Traditional | 01/14/1983SE |
Questions and answers
When was Model Pcx/Emy 525A Microprocesssor Control X-Ray C cleared by the FDA?
Model Pcx/Emy 525A Microprocesssor Control X-Ray C (K850761) received a 510(k) decision of Substantially Equivalent on September 19, 1985, 206 days after the submission was received.
What is the product code of K850761?
The FDA product code is BZN – Cart, Emergency, Cardiopulmonary (Excluding Equipment), a Class I (low risk) device regulated under 21 CFR 868.6175.