FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR
K Number: K011461
·
Decision May 28, 2002
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
165
Applicant Total
2
Review Days
379
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Basic Information
- Device Name
- ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR
- K Number
- K011461
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Access Cardiosystems, Inc.
- Date Received
- May 14, 2001
- Decision Date
- May 28, 2002
- 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 Access Cardiosystems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K020984 | ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS | Aug 14, 2002 | Substantially Equivalent - Subject to Tracking Reg. |