FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BOWEN REUSEABLE/DISPOSABLE ELECTRODE
K Number: K871325
·
Decision Jun 8, 1987
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
328
Applicant Total
14
Review Days
66
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Basic Information
- Device Name
- BOWEN REUSEABLE/DISPOSABLE ELECTRODE
- K Number
- K871325
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Bowen & Company, Inc.
- Date Received
- April 3, 1987
- Decision Date
- June 8, 1987
- Product Code
- DRX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | FDA class 2 | Cardiovascular |
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Other Clearances by Bowen & Company, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K896898 | BOWEN ELECTRODE SKIN PREPATORY CLEANSER | Apr 4, 1990 | Substantially Equivalent |
| K896538 | DISPOSABLE 45 DEGREE SHAVER | Dec 6, 1989 | Substantially Equivalent |
| K873766 | STERNAL POWER AWL | Nov 14, 1988 | Substantially Equivalent |
| K872098 | CREMEEN ALVEOLAR BONE CALIPER | Jul 31, 1987 | Substantially Equivalent |
| K870882 | 45 DEGREE SHAVER | Mar 23, 1987 | Substantially Equivalent |
| K870881 | LOOSE BODY GRASPERS | Mar 23, 1987 | Substantially Equivalent |
| K863146 | BOWEN SUTURE PASSER | Sep 5, 1986 | Substantially Equivalent |
| K863148 | BOWEN KNOT PASSER | Sep 5, 1986 | Substantially Equivalent |
| K863149 | BOWEN PROBE | Sep 5, 1986 | Substantially Equivalent |
| K863147 | GLENOID DRILL | Sep 5, 1986 | Substantially Equivalent |