FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
HEARTSTART 1000
K Number: K883341
·
Decision Sep 12, 1988
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
227
Applicant Total
5
Review Days
34
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Basic Information
- Device Name
- HEARTSTART 1000
- K Number
- K883341
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.5310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Laerdal Mfg. Corp.
- Date Received
- August 9, 1988
- Decision Date
- September 12, 1988
- 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 Laerdal Mfg. Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K902429 | MODIFIED HEARTSTART DEFIBRILLATION ELECTRODE | Sep 27, 1990 | Substantially Equivalent |
| K900169 | MODIFIED HEARTSTART 2000 DEFIBRILLATION ELECTRODE | Jan 26, 1990 | Substantially Equivalent |
| K885186 | HEARTSTART 2000 DEFIBRILLATION ELECTRODE | Feb 23, 1989 | Substantially Equivalent |
| K883344 | HEARTSTART 1000S | Sep 12, 1988 | Substantially Equivalent |