FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BCM-302 COLLIMATING CONE & COMPENSATIN
K Number: K801949
·
Decision Oct 3, 1980
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
10
Applicant Total
8
Review Days
49
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Basic Information
- Device Name
- BCM-302 COLLIMATING CONE & COMPENSATIN
- K Number
- K801949
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.4540
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- B C Medical , Ltd.
- Date Received
- August 15, 1980
- Decision Date
- October 3, 1980
- Product Code
- JZW
- Advisory Committee
- Immunology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JZW | Nephelometer | FDA class 1 | Immunology |
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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 |
| K870205 | ROTAX-II BI-PLANE CIRCULAR ARM | Mar 6, 1987 | Substantially Equivalent |
| K801950 | BCM-600 MINI-SIX EXTRA LG. FIELD ANGIO | Oct 3, 1980 | Substantially Equivalent |