FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 617D
K Number: K863303
·
Decision Sep 5, 1986
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
165
Applicant Total
164
Review Days
11
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Basic Information
- Device Name
- MODEL 617D
- K Number
- K863303
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Quinton, Inc.
- Date Received
- August 25, 1986
- Decision Date
- September 5, 1986
- Product Code
- LDD
- 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 |
|---|---|---|---|
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| K990866 | QUINTON MEDTRACK CR PLUS TREADMILL | Apr 29, 1999 | Substantially Equivalent |
| K971397 | VIEWCATH 3-D CATHETER PULLBACK | Aug 25, 1997 | Substantially Equivalent |
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| K964978 | VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) | May 21, 1997 | Substantially Equivalent |
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