BCM-400C
FDA 510(k) K920862 · B C Medical , Ltd.
510(k) numberK920862
Submission
- Device name
- BCM-400C
- Applicant
- B C Medical , Ltd.
J3y 7p9, CA - Received
- February 25, 1992
- Decision date
- September 30, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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More from Surgvision GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K946378 | BCM 400CPIZI · Traditional | 05/04/1995SE |
| K933100 | ARC-600JAA · Traditional | 11/08/1993SE |
| K933035 | BCM-600TXKPX · Traditional | 10/08/1993SE |
| K890306 | Bcm-Arc 105 X-Ray Mobile UnitIZL · Traditional | 04/17/1989SE |
| K870205 | Rotax-Ii Bi-Plane Circular Arm · Traditional | 03/06/1987SE |
| K801950 | BCM-600 Mini-Six Extra Lg. Field AngioKPX · Traditional | 10/03/1980SE |
| K801949 | BCM-302 Collimating Cone & CompensatinJZW · Traditional | 10/03/1980SE |
Questions and answers
When was BCM-400C cleared by the FDA?
BCM-400C (K920862) received a 510(k) decision of Substantially Equivalent on September 30, 1992, 218 days after the submission was received.
What is the product code of K920862?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.