FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561
K Number: K082861
·
Decision Nov 25, 2008
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
227
Applicant Total
5
Review Days
57
Basic Information
- Device Name
- AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561
- K Number
- K082861
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.5310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC.
- Date Received
- September 29, 2008
- Decision Date
- November 25, 2008
- Product Code
- MKJ
- 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 |
|---|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | FDA class 3 | Cardiovascular |
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Other Clearances by AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K091548 | AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A | Aug 7, 2009 | Substantially Equivalent |
| K073716 | LIFE+CEL OR LIFECEL BATTERY | Apr 11, 2008 | Substantially Equivalent |
| K072596 | LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500 | Jan 24, 2008 | Substantially Equivalent |
| K071164 | LIFE+CEL BATTERY | Dec 7, 2007 | Substantially Equivalent |