FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIAC THERAPHY SYSTEM SCP 900
K Number: K921666
·
Decision Sep 23, 1993
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
165
Applicant Total
3
Review Days
534
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Basic Information
- Device Name
- CARDIAC THERAPHY SYSTEM SCP 900
- K Number
- K921666
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ppg Hellige B.V.
- Date Received
- April 7, 1992
- Decision Date
- September 23, 1993
- 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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