FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER
K Number: K941404
·
Decision Jun 29, 1994
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
18
Applicant Total
26
Review Days
98
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Basic Information
- Device Name
- IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER
- K Number
- K941404
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5325
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hogan & Hartson
- Date Received
- March 23, 1994
- Decision Date
- June 29, 1994
- Product Code
- DRL
- 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 |
|---|---|---|---|
| DRL | Tester, Defibrillator | FDA class 2 | Cardiovascular |
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| K942389 | TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES | Feb 16, 1996 | Substantially Equivalent |
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| K946216 | CARDIOLIPIN A EIA TEST SYSTEM | Jan 24, 1996 | Substantially Equivalent |
| K946215 | CARDIOLIPIN G EIA TEST SYSTEM | Jan 24, 1996 | Substantially Equivalent |
| K946186 | CHAL-2500 | Aug 14, 1995 | Substantially Equivalent for Some Indications |
| K941566 | COMPUSPEAK | Jun 30, 1995 | Substantially Equivalent |