FDA 510(k)
Substantially Equivalent
🇨🇦 Canada
ROTAX-II BI-PLANE CIRCULAR ARM
K Number: K870205
·
Decision Mar 6, 1987
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
8
Review Days
45
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ROTAX-II BI-PLANE CIRCULAR ARM
- K Number
- K870205
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- B C Medical , Ltd.
- Date Received
- January 20, 1987
- Decision Date
- March 6, 1987
- Advisory Committee
- Unknown
- Review Advisory Committee
- RA
- Third Party
- N
Other Clearances by B C Medical , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K946378 | BCM 400CP | May 4, 1995 | Substantially Equivalent |
| K933100 | ARC-600 | Nov 8, 1993 | Substantially Equivalent |
| K933035 | BCM-600TX | Oct 8, 1993 | Substantially Equivalent |
| K920862 | BCM-400C | Sep 30, 1992 | Substantially Equivalent |
| K890306 | BCM-ARC 105 X-RAY MOBILE UNIT | Apr 17, 1989 | Substantially Equivalent |
| K801949 | BCM-302 COLLIMATING CONE & COMPENSATIN | Oct 3, 1980 | Substantially Equivalent |
| K801950 | BCM-600 MINI-SIX EXTRA LG. FIELD ANGIO | Oct 3, 1980 | Substantially Equivalent |