FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KANTRON 504 HEARTSTATION
K Number: K812586
·
Decision Dec 29, 1981
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
165
Applicant Total
2
Review Days
109
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Basic Information
- Device Name
- KANTRON 504 HEARTSTATION
- K Number
- K812586
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Kantron Cardiovascular, Inc.
- Date Received
- September 11, 1981
- Decision Date
- December 29, 1981
- 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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Other Clearances by Kantron Cardiovascular, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K812587 | MONO 2 OXYGEN MONITOR | Oct 6, 1981 | Substantially Equivalent |