FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
HEARTSTART 2000
K Number: K860676
·
Decision Apr 30, 1986
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
227
Applicant Total
7
Review Days
64
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Basic Information
- Device Name
- HEARTSTART 2000
- K Number
- K860676
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.5310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- First Medical Devices Corp.
- Date Received
- February 25, 1986
- Decision Date
- April 30, 1986
- 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 First Medical Devices Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K903657 | MODEL 610 MODIFIED | Sep 4, 1990 | Substantially Equivalent |
| K895185 | FIRST MEDIC MODEL 610P | Oct 27, 1989 | Substantially Equivalent |
| K883584 | FIRST MEDIC MODE 610 | Oct 6, 1988 | Substantially Equivalent |
| K880780 | HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG | May 12, 1988 | Substantially Equivalent |
| K871136 | HEARTSTART 2000, MANUAL DEFIBRILLATOR | May 12, 1987 | Substantially Equivalent |
| K871135 | HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE | May 12, 1987 | Substantially Equivalent |