FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLEAR LEADS-RADIOTRANSPARENT WIRES
K Number: K834583
·
Decision Jan 30, 1984
Classifications
1
FEI Numbers
212
Registration Numbers
212
Same Product Code
5
Applicant Total
164
Review Days
32
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Basic Information
- Device Name
- CLEAR LEADS-RADIOTRANSPARENT WIRES
- K Number
- K834583
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.1175
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Quinton, Inc.
- Date Received
- December 29, 1983
- Decision Date
- January 30, 1984
- Product Code
- IKD
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IKD | Cable, Electrode | FDA class 2 | Physical Medicine |
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| K964978 | VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) | May 21, 1997 | Substantially Equivalent |
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